This document provides an overview and introduction to ISO/IEC 80001-1, which establishes a risk management framework for IT networks incorporating medical devices. It describes why the standard was created, as networks are becoming more complex and integrated. ISO/IEC 80001-1 aims to ensure the safety, effectiveness, and security of medical IT networks by defining roles and responsibilities for manufacturers, healthcare organizations, and regulators during the risk management process. It also introduces the new role of a "Medical IT-Network Risk Manager" within healthcare organizations to help manage risks and communication relating to networked medical devices.
The document discusses upcoming changes to the IEC 60601 standards for medical device safety and performance. Key points include:
- IEC 60601-1 3rd Edition is expected to be published in late 2005, establishing risk management and identifying essential performance as requirements.
- Essential performance is performance necessary to avoid unacceptable risk. Manufacturers will identify which functions are essential.
- IEC 60601-1-2 for electromagnetic compatibility now requires testing essential performance and has expanded immunity test levels.
QAdvis - software risk management based on IEC/ISO 62304Robert Ginsberg
This document provides an overview of risk management for medical device software as outlined in IEC 62304. It discusses:
1) IEC 62304 calls for risk management activities throughout the entire software development lifecycle. This includes identification, analysis, evaluation, control and monitoring of risks.
2) Both quantitative and qualitative techniques can be used for risk analysis, such as FMECA, FTA, HAZOP. Requirement-based and risk-based verification strategies are also expected.
3) Effective risk management relies on good software engineering practices and processes. It aims to regulate verification efforts to balance productivity and compliance.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALMAligned AG
A concrete example of linking risk management using a preliminary hazard analysis approach with the software architecture when applying IEC 62304 in a medical device ALM.
The document discusses the key aspects of the third edition of the 60601-1 general safety standard for medical devices. It highlights that the product risk analysis is the key compliance measure, and worldwide acceptance of the new standard is expected by 2009. Implementation plans include completing an ISO 14971 audit and incorporating the third edition requirements into new product designs.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
The document discusses upcoming changes to the IEC 60601 standards for medical device safety and performance. Key points include:
- IEC 60601-1 3rd Edition is expected to be published in late 2005, establishing risk management and identifying essential performance as requirements.
- Essential performance is performance necessary to avoid unacceptable risk. Manufacturers will identify which functions are essential.
- IEC 60601-1-2 for electromagnetic compatibility now requires testing essential performance and has expanded immunity test levels.
QAdvis - software risk management based on IEC/ISO 62304Robert Ginsberg
This document provides an overview of risk management for medical device software as outlined in IEC 62304. It discusses:
1) IEC 62304 calls for risk management activities throughout the entire software development lifecycle. This includes identification, analysis, evaluation, control and monitoring of risks.
2) Both quantitative and qualitative techniques can be used for risk analysis, such as FMECA, FTA, HAZOP. Requirement-based and risk-based verification strategies are also expected.
3) Effective risk management relies on good software engineering practices and processes. It aims to regulate verification efforts to balance productivity and compliance.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALMAligned AG
A concrete example of linking risk management using a preliminary hazard analysis approach with the software architecture when applying IEC 62304 in a medical device ALM.
The document discusses the key aspects of the third edition of the 60601-1 general safety standard for medical devices. It highlights that the product risk analysis is the key compliance measure, and worldwide acceptance of the new standard is expected by 2009. Implementation plans include completing an ISO 14971 audit and incorporating the third edition requirements into new product designs.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
IEC 62304 is an international standard that defines software development lifecycle requirements for medical device software. It requires that all aspects of the software development life cycle be scrutinized to ensure patient safety when software is involved. The standard establishes software safety classes A, B, and C based on the possible risk to health from software failures. It also outlines numerous requirements for each class, including developing plans, requirements, designs, testing procedures, problem resolution processes, and more. Upon completion, all documentation should be submitted to a test lab for review to obtain certification.
Risk Management in IES 60601. Medical Devices, Creation and content of RMF, Methods for the visualization and identification of harms and hazards,
Creating a RMF – Minimal Documentation,
Common errors when creating a RMF.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Management of e-SOP in GxP environment .Anand Pandya
Management and use of electronic SOP for use in GxP environment . How can electronic version of SOP be prepared and used in compliance with regulatory environment .
Health apps regulation and quality control case studies and session 2 present...3GDR
The document discusses regulation and quality control of health apps. It begins with an overview of the digital health landscape and how different types of apps may be regulated to varying degrees. It then discusses challenges in managing chronic diseases and how data from apps and devices could potentially help patients if transformed and delivered in an actionable way. The rest of the document discusses regulatory frameworks for medical software and apps, standards that may apply, and issues to consider like safety, security, usability and more. It also provides examples of how safety cases are used in other industries like nuclear to help build confidence in critical systems.
Human factors and ergonomics society 20120311Jones Wu
The document summarizes a presentation on new human factors standards and guidance for medical devices. It provides an overview of the human factors engineering process, standards, and changes now in progress. It notes that international standards are being updated to harmonize with FDA guidance, which is increasing expectations for human factors work. This includes requirements for contextual inquiry, known use error analysis, risk analysis, and validated usability testing according to prioritized tasks.
This document discusses using agile software development methods for medical device software in a compliant way. It provides an overview of agile concepts like Scrum, test-driven development, and continuous integration. It also addresses how standards like IEC 62304 and risk management can help integrate agile into a regulated environment. The document recommends starting small with agile and focusing on visualization, communication, and integrating risk management activities.
Abbott overview medical device human factors standardsJones Wu
The document provides an overview of international medical device human factors standards, outlining their history and purposes. It summarizes that IEC 62366:2007 is now the key usability engineering standard, with IEC 60601-1-6:2010 pointing to it, and HE-74 being incorporated into IEC 62366 as an annex. Future revisions are planned to split and update IEC 62366 by 2014 to address additional topics and harmonize with FDA guidance.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
The FDA has their Design Controls in the Code of Federal Regulations Title 21 Part 820.30, then for outside the US, we have ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes, and finally there is ISO 14971 Medical devices — Application of risk management to medical devices.
How can the New Product Development (NPD) process make conforming to these standards into an advantage and accomplish the appropriate Reliability activities in their proper place and sequence to avoid those expensive “loopbacks” (which are really NPD rework)? Can a NPD project steer clear of situations requiring compromise in Reliability to avoid repeating clinical trials or to preserve the project schedule?
Can a company avoid recalls for Reliability issues by knowing what the Reliability will be before product release?
An optimal New Product Development process will be presented that successfully deals with these challenges.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
This document summarizes key aspects of legal and regulatory issues related to medical device software in the European Union. It discusses when software is considered a medical device and must be CE marked. It also outlines manufacturer obligations, classification rules, standards and guidance, clinical evaluation requirements, and emerging issues around networked devices and eHealth.
This document provides an overview of a presentation on computer system validation practices. It discusses regulatory requirements, best practices guidance, quality risk management, and life cycles for computer systems and validation. The presentation covers topics such as ICH guidelines, GAMP5, risk-based approaches to validation, and integration of validation life cycles with system development and project management life cycles. It also references sources such as FDA guidance documents and international standards. The document consists of an agenda and slides outlining key concepts and approaches to computer system validation.
Computer System Validation is not mere testingAnand Rao. C
Computer system validation for life science software is critical to ensure patient safety and avoid drug recalls, as malfunctions can cause serious harm or death. Regulatory agencies strictly govern the pharmaceutical industry and require validation throughout the software development lifecycle to comply with quality standards. Following guidance from regulations like Part 11, GAMP, PIC/S and ISPE can help organizations properly validate their systems and address issues that have previously led to over 10% of drug recalls due to software defects.
This document discusses computerized system validation (CSV) and quality assurance principles for ensuring reliable computerized systems. It defines CSV as establishing evidence that a process will consistently produce products meeting specifications. The validation process should be performed during software development and includes master planning, installation qualification, operational qualification, and performance qualification. Quality assurance focuses on processes, while quality control focuses on products. The document also outlines responsibilities for validation, and the software development life cycle of planning, designing, building, testing, deploying, using, and retiring a system.
This document provides definitions and explanations of key concepts related to computerized system validation (CSV) and regulatory compliance. It defines terms like CSV, GxP, data integrity, validation, and regulatory bodies like the US FDA, EMA, and CDSCO. It also explains concepts such as qualification, deviation handling, change control, and documentation for validated systems like user requirements, validation plans, and reports. Overall, the document serves as an introduction to the important terminology and principles of CSV and compliance.
eRX Webinar - State Health Information Exchange Leadership ForumBrian Ahier
The document discusses various potential roles that states or state-designated entities (SDEs) can play in supporting electronic prescribing (ePrescribing) to help meet meaningful use requirements. It outlines conducting a gap analysis of ePrescribing capabilities; tracking adoption; developing education campaigns; examining regulations; coordinating stakeholder strategies; engaging pharmacies; updating Medicaid; increasing provider awareness; facilitating electronic prescribing of controlled substances; and monitoring emerging issues. Examples from Minnesota, Rhode Island, Florida and Tennessee are provided.
IEC 62304 is an international standard that defines software development lifecycle requirements for medical device software. It requires that all aspects of the software development life cycle be scrutinized to ensure patient safety when software is involved. The standard establishes software safety classes A, B, and C based on the possible risk to health from software failures. It also outlines numerous requirements for each class, including developing plans, requirements, designs, testing procedures, problem resolution processes, and more. Upon completion, all documentation should be submitted to a test lab for review to obtain certification.
Risk Management in IES 60601. Medical Devices, Creation and content of RMF, Methods for the visualization and identification of harms and hazards,
Creating a RMF – Minimal Documentation,
Common errors when creating a RMF.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Management of e-SOP in GxP environment .Anand Pandya
Management and use of electronic SOP for use in GxP environment . How can electronic version of SOP be prepared and used in compliance with regulatory environment .
Health apps regulation and quality control case studies and session 2 present...3GDR
The document discusses regulation and quality control of health apps. It begins with an overview of the digital health landscape and how different types of apps may be regulated to varying degrees. It then discusses challenges in managing chronic diseases and how data from apps and devices could potentially help patients if transformed and delivered in an actionable way. The rest of the document discusses regulatory frameworks for medical software and apps, standards that may apply, and issues to consider like safety, security, usability and more. It also provides examples of how safety cases are used in other industries like nuclear to help build confidence in critical systems.
Human factors and ergonomics society 20120311Jones Wu
The document summarizes a presentation on new human factors standards and guidance for medical devices. It provides an overview of the human factors engineering process, standards, and changes now in progress. It notes that international standards are being updated to harmonize with FDA guidance, which is increasing expectations for human factors work. This includes requirements for contextual inquiry, known use error analysis, risk analysis, and validated usability testing according to prioritized tasks.
This document discusses using agile software development methods for medical device software in a compliant way. It provides an overview of agile concepts like Scrum, test-driven development, and continuous integration. It also addresses how standards like IEC 62304 and risk management can help integrate agile into a regulated environment. The document recommends starting small with agile and focusing on visualization, communication, and integrating risk management activities.
Abbott overview medical device human factors standardsJones Wu
The document provides an overview of international medical device human factors standards, outlining their history and purposes. It summarizes that IEC 62366:2007 is now the key usability engineering standard, with IEC 60601-1-6:2010 pointing to it, and HE-74 being incorporated into IEC 62366 as an annex. Future revisions are planned to split and update IEC 62366 by 2014 to address additional topics and harmonize with FDA guidance.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
The FDA has their Design Controls in the Code of Federal Regulations Title 21 Part 820.30, then for outside the US, we have ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes, and finally there is ISO 14971 Medical devices — Application of risk management to medical devices.
How can the New Product Development (NPD) process make conforming to these standards into an advantage and accomplish the appropriate Reliability activities in their proper place and sequence to avoid those expensive “loopbacks” (which are really NPD rework)? Can a NPD project steer clear of situations requiring compromise in Reliability to avoid repeating clinical trials or to preserve the project schedule?
Can a company avoid recalls for Reliability issues by knowing what the Reliability will be before product release?
An optimal New Product Development process will be presented that successfully deals with these challenges.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
This document summarizes key aspects of legal and regulatory issues related to medical device software in the European Union. It discusses when software is considered a medical device and must be CE marked. It also outlines manufacturer obligations, classification rules, standards and guidance, clinical evaluation requirements, and emerging issues around networked devices and eHealth.
This document provides an overview of a presentation on computer system validation practices. It discusses regulatory requirements, best practices guidance, quality risk management, and life cycles for computer systems and validation. The presentation covers topics such as ICH guidelines, GAMP5, risk-based approaches to validation, and integration of validation life cycles with system development and project management life cycles. It also references sources such as FDA guidance documents and international standards. The document consists of an agenda and slides outlining key concepts and approaches to computer system validation.
Computer System Validation is not mere testingAnand Rao. C
Computer system validation for life science software is critical to ensure patient safety and avoid drug recalls, as malfunctions can cause serious harm or death. Regulatory agencies strictly govern the pharmaceutical industry and require validation throughout the software development lifecycle to comply with quality standards. Following guidance from regulations like Part 11, GAMP, PIC/S and ISPE can help organizations properly validate their systems and address issues that have previously led to over 10% of drug recalls due to software defects.
This document discusses computerized system validation (CSV) and quality assurance principles for ensuring reliable computerized systems. It defines CSV as establishing evidence that a process will consistently produce products meeting specifications. The validation process should be performed during software development and includes master planning, installation qualification, operational qualification, and performance qualification. Quality assurance focuses on processes, while quality control focuses on products. The document also outlines responsibilities for validation, and the software development life cycle of planning, designing, building, testing, deploying, using, and retiring a system.
This document provides definitions and explanations of key concepts related to computerized system validation (CSV) and regulatory compliance. It defines terms like CSV, GxP, data integrity, validation, and regulatory bodies like the US FDA, EMA, and CDSCO. It also explains concepts such as qualification, deviation handling, change control, and documentation for validated systems like user requirements, validation plans, and reports. Overall, the document serves as an introduction to the important terminology and principles of CSV and compliance.
eRX Webinar - State Health Information Exchange Leadership ForumBrian Ahier
The document discusses various potential roles that states or state-designated entities (SDEs) can play in supporting electronic prescribing (ePrescribing) to help meet meaningful use requirements. It outlines conducting a gap analysis of ePrescribing capabilities; tracking adoption; developing education campaigns; examining regulations; coordinating stakeholder strategies; engaging pharmacies; updating Medicaid; increasing provider awareness; facilitating electronic prescribing of controlled substances; and monitoring emerging issues. Examples from Minnesota, Rhode Island, Florida and Tennessee are provided.
This document discusses mobile, wearable, and smart technologies in the context of prosthetics. It provides an overview of technologies such as smart textiles, electronics, materials, and software that are relevant to prosthetics. It then discusses challenges with applying these technologies, including limited control capabilities compared to the human body, lack of proprioception and feedback, and regulatory hurdles. Examples are given of recent advances in prosthetic control through pattern recognition and implanted sensors. In conclusion, the document notes that while devices are getting smarter, perfect integration remains difficult due to challenges with control and regulations.
As the impact of healthcare reform on the U.S. delivery system comes into focus, there is little doubt that it is a “game changer” for clinical engineering and biomedical equipment technology. Carol will describe and discuss the future of the CE and BMET professions under new regulations and a new payment system. She will address why medical devices will cost much more, why equipment must have longer life cycles, why CEs and BMETs will and must have more involvement in IT-related activities, how CEs’ and BMETs’ responsibilities in regulatory compliance will expand and how you can prepare for this new environment.
About Carol Davis-Smith, CCE
Career Summary
Carol Davis-Smith is a Director in Premier’s Consulting Solution Division with responsibility for the development and deployment of capital lifecycle management processes and tools to Premier staff and owners.
Education and Affiliations
Ms. Davis-Smith received a B.S. in bioengineering technology
from the University of Dayton and an M.S. in engineering from the University of Arizona. She is a certified clinical engineer and a member of the Association for the Advancement of Medical Instrumentation (AAMI). Over the past 20 years, she has presented and published papers on a variety of clinical engineering and capital contracting topics. In 2009, Ms. Davis-Smith received the AAMI Clinical Engineering Achievement Award.
Risk Management of Medical Devices Connected To IT Networks per ANSI / IEC 8001
Published 2011 for informational awareness, non-profit, non-consulting purposes of publicly available resources.
Disclaimer
This document is made available at this web site for educational informational purposes only. It is not intended for the purpose of providing legal advice or regulatory advise as ISO 8001 was in draft form in 2011 when this document was originally published.
You should contact your attorney and corporate security / risk management officer(s) to obtain advice with respect to any particular security risk issue or problem. No obligations, rights or indemnification is given or implied by the public sharing of this document. Use of and access to this document on this Web site or any of the e-mail links, materials, etc., contained within the document do not create an attorney-client relationship, consulting between the author(s), legal and / or medical risk management advice in any context between the user or browser.
The opinions expressed at or through this site are the opinions of the individual author to the best of public knowledge in 2011 only. Therefore it does not reflect the opinions of any firm, ISO 8001 committee or any individual attorney or legally binding statue, regulation,etc.
Regelgeving medische alarmering (Martijn van der Meulen, Zetacom) - Zetacom Z...Zetacom
De regelgeving omtrent medische alarmering staat op het punt strenger te worden en dat heeft serieuze consequenties voor elk ziekenhuis. Veel ziekenhuizen zijn hier op één of andere manier mee bezig. We willen een aantal aspecten hiervan belichten en op die manier onder de aandacht brengen.
Zetacom ZORG Seminar, 31 oktober 2013
www.zetacom.nl/zorg-seminar
Health apps regulation and quality control case studies and session 2 present...3GDR
The document discusses regulation and quality control of health apps. It begins with an overview of the digital health landscape and how different types of apps may be regulated to varying degrees. It then discusses challenges in managing chronic diseases and how data from apps and devices could potentially help transform care if delivered in an actionable way. The rest of the document discusses regulatory frameworks for medical software and apps, standards that may apply, and issues to consider like safety, security, usability and how to demonstrate safety for apps and systems that include software.
Best practices paper on the risks, standards and challenges of Health Risk Management- Testing in the Healthcare domain by Devi.K from Siemens. Paper submitted during QAI's 12th International Software Testing Conference
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...TGA Australia
The document summarizes the results of a consultation on proposed reforms to the regulation of software as a medical device in Australia. It discusses key points from international approaches to classifying and regulating software, proposed new classification rules and essential principles for software in Australia, and the results of the consultation which found general agreement with the proposals among respondents.
Understanding Risk Management & Cyber security Principles in Medical DevicesKeerthi Gunasekaran
The reality is Risk Management is one of the more complex aspects of compliance and product efficacy, as risk comes in so many forms and perceptions, and on top of it risk assessments can be interpreted differently across a sector. Often decisions must be made with not enough data to accurately quantify risks. This course teaches the principles and org mindset needed to manage RM and setup cyber security. An Excerpt from ASQ MN presentation by the author Keerthi Gunasekaran
Presentation: Cybersecurity considerations for medical devices - From the TGA...TGA Australia
The Australian regulatory framework for medical devices already captures cybersecurity. Manufacturers have been considering security in their design, and the Therapeutic Goods Administration (TGA) has been assessing and regulating the security of medical devices through the Essential Principles. However, the number of networked devices is growing, the risk profile is changing, and public awareness of cybersecurity as a risk is increasing.
This changing landscape has created new challenges for regulators of medical devices, including poor or unclear standardisation, sharing information, publication of vulnerabilities and exploits by users and security researchers, and poor transparency of expectations between stakeholders.
TGA is currently undertaking multiple projects to improve the regulation of medical device cybersecurity in Australia. These include, building on the existing capabilities to assess and measure medical device security, consulting with industry and other stakeholders on their challenges and expectations, and working to improve standardisation.
IOT BASED HEALTH MONITORING SYSTEM FOR COVID 19 PATIENTIRJET Journal
This document describes an Internet of Things (IoT)-based health monitoring system for COVID-19 patients. The system measures patients' pulse rate, body temperature, and oxygen saturation using sensors connected to an Arduino Uno microcontroller. These vital signs are displayed on an LCD screen and sent to a mobile app for remote monitoring. The system was tested on 5 human subjects and was able to quickly obtain and store health data. Compared to other systems, this IoT-based approach could be very useful for monitoring COVID-19 patients during the ongoing pandemic. It allows for remote patient monitoring which can help reduce costs and free up hospital space for more critical cases.
Cloud computing security or, more simply, cloud security refers to a broad set of policies, technologies, applications, and controls utilized to protect virtualized IP, data, applications, services, and the associated infrastructure of cloud computing. It is a sub-domain of computer security, network security, and, more broadly, information security.
Security issues associated with the cloud
Cloud computing and storage provide users with capabilities to store and process their data in third-party data centers Organizations use the cloud in a variety of different service models (with acronyms such as SaaS, PaaS, and IaaS) and deployment models (private, public, hybrid, and community).
Security concerns associated with cloud computing are typically categorized in two ways: as security issues faced by cloud providers (organizations providing software-, platform-, or infrastructure-as-a-service via the cloud) and security issues faced by their customers (companies or organizations who host applications or store data on the cloud). The responsibility is shared, however, and is often detailed in a cloud provider's "shared security responsibility model" or "shared responsibility model." The provider must ensure that their infrastructure is secure and that their clients’ data and applications are protected, while the user must take measures to fortify their application and use strong passwords and authentication measures.
When an organization elects to store data or host applications on the public cloud, it loses its ability to have physical access to the servers hosting its information. As a result, potentially sensitive data is at risk from insider attacks. According to a 2010 Cloud Security Alliance report, insider attacks are one of the top seven biggest threats in cloud computing. Therefore, cloud service providers must ensure that thorough background checks are conducted for employees who have physical access to the servers in the data center. Additionally, data centers are recommended to be frequently monitored for suspicious activity.
The regulation of software: Medicines, biologicals, blood, tissues and devicesTGA Australia
This presentation is an overview of the software regulated by the TGA, a brief introduction to the International Medical Device Regulators' Forum's Software as a Medical Device project and details of how the TGA takes a systems approach to the regulation of software.
This document describes a dynamic medical machine that is deployed in rural areas without easy access to doctors. The machine contains sensors like a temperature sensor, heart rate sensor, and ultrasonic sensor to monitor patients' vital signs. It is connected to a doctor via video and audio calls to allow virtual consultations. Based on the doctor's diagnosis and prescription, the machine automatically dispenses the appropriate medicines to the patient. This aims to make healthcare more accessible for common illnesses in remote locations while reducing costs.
A presentation by Tracy Rausch, CEO of DocBox and Chip Block of Evolver Inc. on medical device security & patient monitoring. Presented at The Security of Things Forum on Sept. 10, 2015.
This document provides an introduction to medical device security. It defines medical devices and provides examples. Intended use determines if a device is regulated. Software can be a medical device. Regulations and standards like IEC 62443 govern security. Old devices increase interconnectivity and associated risks. Security goals are confidentiality, integrity and availability to prevent patient harm. Common vulnerabilities include unpatched systems and weak credentials. Risk assessments must consider safety impacts. Manufacturers must integrate security into development and handle incidents and vulnerabilities.
Network Connected Medical Devices - A Case StudySophiaPalmira
In this session, we welcome Shankar Somasundaram, CEO of Asimily, Priyanka Upendra, Quality Compliance Director at Banner Health, and Carrie Whysall. Director of Managed Security Services at CynergisTek.
Together, they will discuss medical device security, covering all you need to know from medical device assessments to remediation efforts. Attendees will leave this session knowing how to apply what they have learned about medical device security in real life.
ealth Monitoring System in Emergency Using IoT: A ReviewIRJET Journal
This document reviews remote health monitoring systems using IoT technology. It discusses how sensors can detect patient vitals, data can be sent to cloud storage, and data can be remotely viewed by doctors. This allows doctors to monitor patient health even when not in the hospital. The document outlines the components of such a system, including sensors to detect vitals, transmission of data to the cloud, and an interface to view the data remotely. It also reviews several existing studies on IoT-based health monitoring systems and their findings. In general, these systems allow for continuous remote patient monitoring, early disease detection, and reduced healthcare costs compared to traditional hospital-based monitoring.
IRJET - Medical Analysis using Virtual RealityIRJET Journal
This document describes a proposed medical analysis system using virtual reality. The system would involve sensors attached to patients in a hospital to monitor vital signs like temperature, heart rate, and respiration. The sensor data would be sent wirelessly to augmented reality glasses worn by doctors. If a patient's vital signs exceed a threshold, the doctor would be alerted. The system is intended to allow real-time remote patient monitoring using virtual reality technologies. It could involve hardware components like sensors, a microcontroller, and wireless transmitter, as well as software like an IDE and embedded C programming.
Speed your time to market by following the step-by-step instructions.
You'll learn the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
See the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.
Specifically, you will learn:
-The scope of IEC 60601-1 standards & if they apply to your product.
-What you need to know to classify your products to the IEC 60601-1 series.
-What is an isolation diagram and how does that help me with my design?
-Determine the applicable tests for your device.
-What are the marking and labeling requirements for the device?
-Know your critical components.
-What pre-tests to run and what’s not worth testing?
-Resources to help with this process and ways to reduce the paperwork off your backs.
Watch the presentation here: https://www.greenlight.guru/webinar/iec-60601-1
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given device...
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
The document provides an overview of the product development cycle for medical devices. It discusses that medical devices are highly regulated and must meet regulatory standards to be approved for use. The development process involves risk analysis, usability testing, clinical evaluation and verification to ensure safety and effectiveness for the intended use before a device can be certified and placed on the market. Standards provide guidelines for quality management, risk management, and specific product categories that must be followed.
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
Similar to ISO/IEC80001 - Do we need another standard? (20)
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
buy old yahoo accounts buy yahoo accountsSusan Laney
As a business owner, I understand the importance of having a strong online presence and leveraging various digital platforms to reach and engage with your target audience. One often overlooked yet highly valuable asset in this regard is the humble Yahoo account. While many may perceive Yahoo as a relic of the past, the truth is that these accounts still hold immense potential for businesses of all sizes.
SATTA MATKA SATTA FAST RESULT KALYAN TOP MATKA RESULT KALYAN SATTA MATKA FAST RESULT MILAN RATAN RAJDHANI MAIN BAZAR MATKA FAST TIPS RESULT MATKA CHART JODI CHART PANEL CHART FREE FIX GAME SATTAMATKA ! MATKA MOBI SATTA 143 spboss.in TOP NO1 RESULT FULL RATE MATKA ONLINE GAME PLAY BY APP SPBOSS
How MJ Global Leads the Packaging Industry.pdfMJ Global
MJ Global's success in staying ahead of the curve in the packaging industry is a testament to its dedication to innovation, sustainability, and customer-centricity. By embracing technological advancements, leading in eco-friendly solutions, collaborating with industry leaders, and adapting to evolving consumer preferences, MJ Global continues to set new standards in the packaging sector.
Recruiting in the Digital Age: A Social Media MasterclassLuanWise
In this masterclass, presented at the Global HR Summit on 5th June 2024, Luan Wise explored the essential features of social media platforms that support talent acquisition, including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok.
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfthesiliconleaders
In the recent edition, The 10 Most Influential Leaders Guiding Corporate Evolution, 2024, The Silicon Leaders magazine gladly features Dejan Štancer, President of the Global Chamber of Business Leaders (GCBL), along with other leaders.
Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
Company Valuation webinar series - Tuesday, 4 June 2024FelixPerez547899
This session provided an update as to the latest valuation data in the UK and then delved into a discussion on the upcoming election and the impacts on valuation. We finished, as always with a Q&A
Company Valuation webinar series - Tuesday, 4 June 2024
ISO/IEC80001 - Do we need another standard?
1. Introduction to ISO/IEC 80001-1
---
Application of Risk
management for IT-networks
incorporating Medical devices
Why do we need another
standard?
2. Introduction of Speakers
Robert.Ginsberg@QAdvis.com
26 years in software development
18 years in Medical Device software
Participated in > 20 audits, FDA, MDD etc.
Co-author of IEC/ISO 62304 (80001-1 and 80002-X)
Working member of Cenelek TK-62 and JWG3
3. The bar is raised over time
Accident
People get
hurt or die
Public
reaction
New laws
and
regulations
4. Media report the mishaps, and we as
the society don’t accept as we mature
5. What is the problem we are facing
with MedTech and IT?
Heterogeneous networks
Multi-vendor / Multi-modality
Mix of Medical devices – IT
Unanticipated emergent behaviors
6. Integration of Medical devices is
becoming a challenge
Manufacturers
Devices
Involuntary Integrators
10. IEC/ISO 80001 is made to resolve
this problem
IEC - ISO
• Key stakeholder
• Medical Device Manufacturers
• Hospitals
• FDA
Published in 2010
11. Risk management is the key
activity in 80001
Responsible organization
• Accountable for the use and maintenance of an
ME Equipment or an ME System
Hazards of Medical Devices in networks
• ISO 14971
Residual risk
• Approval by appropriate person
12. There are three standards that are
tightly interrelated
IEC
80001-1
IEC
60101-1
ISO
14971
13. ISO 14971 is the established
standard for Risk Management
• Identification of Intended use
• Identification of Hazards, FTA and FMECA
• Estimation of Risk(s)
Risk analysis
Risk evaluation
• Option analysis
• Implementation of risk control measures
• Risk/benefit analysis
• Risks from risk control measures
• Completeness of risk control
Risk control
Residual risk
Risk management report
(Post-) Production
14. IEC 60601-series assure Basic
Safety and Essential performance
INTERNATIONAL IEC
STANDARD 60601-1
Medical electrical equipment
Part 1
General requirements
INTERNATIONAL IEC
STANDARD 60601-2-1
Medical electrical equipment
Part 2
Particular requirements
for medical accelerators
INTERNATIONAL IEC
STANDARD 60601-1-2
Medical electrical equipment
Part 1
General requirements
for EMC
INTERNATIONAL IEC
STANDARD 60601-1-3
Medical electrical equipment
Part 1
General requirements
for radiation protection
INTERNATIONAL IEC
STANDARD 60601-1-6
Medical electrical equipment
Part 1
General requirements
for usability
Collateral (Common)
Particular
(Specialized)
15. New Hazards are arising from
networks
• IEC 60601-1 3rd edition tries to address this
o EU – 2012 -06-01
o USA – 2013-06-30
• Targets the manufacturers
16. IEC 60601-1 3rd ed. Section 14.13
... the technical description shall instruct the
RESPONSIBLE ORGANIZATION that:
- connection of the PEMS to a NETWORK/DATA
COUPLING that includes other equipment
could result in previously unidentified
RISKS
- the RESPONSIBLE ORGANIZATION should
identify, analyze, evaluate and control
these RISKS
17. IEC 60601-1 3rd ed. Section 14.13
... the technical description shall instruct the
RESPONSIBLE ORGANIZATION that:
- changes to the NETWORK/DATA COUPLING
could introduce new RISKS and require
additional analysis
- …
18. The obvious solution is to extend
the Instructions for use
IEC60601-1
Section
14.13
Instructions
for use
19. ISO/IEC 80001 enables an interface
between manufacturers and caregivers
Manufacturer
60601-1
Caregiver
14971
80001
20. The same interface will be valid for
stand-alone software
Manufacturer
Caregiver
14971
82304
80001
22. The update problem from the
responsible organizations point of view
If a medical device is connected to a network
that has internet access, it may be
vulnerable to viruses.
What should the responsible organization do
when Microsoft announces an urgent update
that applies to a medical device?
23. The update problem from the
manufacturers point of view
If a medical device is connected to a network
that has internet access, it may be
vulnerable to viruses.
What should the manufacturer do when
Microsoft announces an urgent update that
applies to a medical device?
24. Proper Risk Management is part of
the solution
Draft Part 2-x: Step by Step Risk Management
of Medical IT-Networks; Practical Applications
and Examples:
• Risk management of the Update
• Actions based on the outcome
• Change permit
• Cooperation
• Validation by manufacturer
25. Who needs to do what?
Manufacturers
Responsible organizations
Regulators
New Roles
26. Who needs to do What?
Manufacturers
Responsible organizations
Regulators
New Roles
27. What manufacturers must do
Design for networking
State what the network connection is for
Narrow the scope
Inform about risks
28. Who needs to do What?
Manufacturers
Responsible organizations
Regulators
New Roles
29. A new role has to be shaped out
Medical IT-Network Risk Manager
IT Dept Biomed Dept
30. Who needs to do What?
Manufacturers
Responsible organizations
Regulators
New Roles
31. What the Regulator must do
IEC 80001-1 is not, and will probably not be,
harmonized with the MDD.
There is no correspondance to CE-marking for
care-givers.
So regulators (of healthcare organizations) have
to find a way of introducing it.
32. Socialstyrelsen har lagt en bra grund
för IEC/ISO 80001
SOCFS Innehåll Aspekt
2005:12, 7§ Ledningssystemet skall säkerställa ... Säker
användning och hantering av produkter,
försörjningssystem och informationssystem
Effectiveness
Safety
2008:14, 3§ Vårdgivaren ska utse ... personer ...
riskanalyser som har utförts avseende
informationssäkerheten
Data and
system
security
2008:1, 4§ Vårdgivaren ... egentillverkade
medicintekniska produkternas säkerhet ...
CE-märkta produkter
Safety
34. Who needs to do What?
Manufacturers
Responsible organizations
Regulators
New Roles
35. A new role for the responsible
organization is needed
Standard IEC 80001-1
defines:
Medical IT-Network
Risk Manager
36. A New Role with lots of
responsibilities
Management of RM process
Reporting to Top Mgmt
Communicating
Collecting information
Planning changes
Authorizing changes
Informing on risks
Monitoring all IT projects
37. The role is to be a spider in the web
Top Management
Risk IT department
Policies
RM
MGR
Risk
Management
File
Clinical department
Bioengineering dept
Manufacturer
Manufacturer
Subcontractor
38.
39. The content of the standard 80001-1
1 Scope
2 Terms and Definitions
3 Roles and Responsibilites
4 Life Cycle RM in medical IT-networks
5 Document control
40. Higlights in Scope section
1 Scope
2 Terms and Definitions
3 Roles and responsibilites
4 Life Cycle RM in medical IT-networks
5 Document control
41. The responsible organization is the
primary target of the standard
• This standard applies after a MEDICAL
DEVICE has been acquired by a
RESPONSIBLE ORGANIZATION and is a
candidate for incorporation into an IT-NETWORK.
• To address
– Safety
– Effectiveness
– Data and system security
42. 80001 extends the definition of harm
Key properties
SAFETY
EFFECTIVENESS
DATA AND SYSTEM
SECURITY
43. Higlights in Terms Section
1 Scope
2 Terms and Definitions
3 Roles and responsibilites
4 Life Cycle RM in medical IT-networks
5 Document control
44. 2 Terms and definitions
IT-NETWORK - IT-NÄTVERK
• A system or systems composed of communicating nodes and
transmission links to provide physically linked or wireless
transmission between two or more specified communication
nodes
KEY PROPERTIES - NYCKELEGENSKAPER
• Three risk managed characteristics (SAFETY,
EFFECTIVENESS, and DATA AND SYSTEMS SECURITY) of
MEDICAL IT-NETWORKS
45. 2 Terms and definitions
RESPONSIBLE ORGANIZATION - VÅRDGIVAREHFP
• Entity accountable for the use and maintenance of a MEDICAL
IT-NETWORK
TOP MANAGEMENT - HÖGSTA LEDNINGEN
• Person or group of people who direct(s) and control(s) the
RESPONSIBLE ORGANIZATION accountable for a MEDICAL
IT-NETWORK at the highest level
46. 2 Terms and definitions
HARM – SKADA [VårdskadaHFP]
• Physical injury or damage to the health of people, or damage to property or
the environment, or reduction in EFFECTIVENESS, or breach of DATA AND
SYSTEM SECURITY
RISK - RISKHFP
• Combination of the probability of occurrence of HARM and the severity of
that HARM
RISK MANAGEMENT - RISKHANTERINGHFP
• Systematic application of management policies, procedures and practices to
the tasks of analyzing, evaluating, controlling, and monitoring RISK
RISK MANAGEMENT FILE – RISKHANTERINGSDOKU-MENTATION
• Set of records and other documents that are produced by RISK
MANAGEMENT
47. 2 Terms and definitions
CHANGE PERMIT - Ändringsmedgivande
• An outcome of the RISK MANAGEMENT PROCESS
consisting of a document that allows a specified
change or type of change without further RISK
MANAGEMENT Activities subject to specified
constraints
EVENT MANAGEMENT – Händelshantering
• A PROCESS that ensures that all events that can or
might negatively impact the operation of the IT-NETWORK
are captured, assessed, and managed in
a controlled manner
48. IEC/ISO 80001-1 is a process
standard
New or
Change of
Medical IT-network
Change
Permit?
Change Control Life environment
”Project”
Risk management
Go
live!
Monitoring
Event
management
Yes
No
Unacceptable
risk
49. A CHANGE PERMIT can help you to make
Risk Management efficient
CHANGE PERMIT:
an outcome of the RISK MANAGEMENT
PROCESS consisting of a document that
allows a specified change or type of change
without further RISK MANAGEMENT
Activities subject to specified constraints
50. A Change Permit is a way of
reusing Risk Management work
Patient monitors type XXX may be added to or
removed from the High-dependency ward’s shielded
wireless network subject to the following conditions:
• No more than 15 patient monitors may be connected to the
network at any one time.
• An up-to-date record of the wireless devices in use in the ward is
to be kept available for inspection at the nursing station.
If these conditions are not met, this permit is void and
the full Risk Management process must be used.
51. Higlights in Roles and responsibilities
section
1 Scope
2 Terms and Definitions
3 Roles and responsibilites
4 Life Cycle RM in medical IT-networks
5 Document control
52. There are several ways of
implementing the Risk Manager role
Respon-sible
organiza
-tion
Medical IT-network
Risk
Manager
Top
mana-gement
Medical
Device
Manufac
-turer
IT Tech
provi-ders
53. Higlights in section on Lifecycle
1 Scope
2 Terms and Definitions
3 Roles and responsibilites
4 Life Cycle RM in medical IT-networks
5 Document control
54. 80001 is based on 14971, which is
“the” standard for Risk Management
• Identification of Intended use
• Identification of Hazards, FTA and FMECA
• Estimation of Risk(s)
Risk analysis
Risk evaluation
• Option analysis
• Implementation of risk control measures
• Risk/benefit analysis
• Risks from risk control measures
• Completeness of risk control
Risk control
Residual risk
Risk Management File
(Post-) Go-Live
60. Higlights in Document Control section
1 Scope
2 Terms and Definitions
3 Roles and responsibilites
4 Life Cycle RM in medical IT-networks
5 Document control
61. The Medical IT-Network Risk
Management File is the key document
Trace each identified Hazard to:
• Risk Analysis
• Risk Evaluation
• Implementation and Verification of the
Risk Control Measures
• The assessment of the acceptability of
any Residual Risk(s) with approval
62. There are three new work items on
their way to clarify 80001
Step by Step Risk Management of Medical IT-Networks;
Practical Applications and Examples
• Risk management hands-on
Guidance for the communication of medical device
security needs, risks and controls
• IT Technology for security
Guidance for wireless network
• Hands-on networking
63. Summary
Care givers are facing a challenge
This will propagate to manufacturers
Manufacturers of stand-alone SW might
have a large hurdle to pass
64. Building a solid Risk Mana-gement
process can enable
productivity
Synergus can contribute with
Auditing and reviews
Mentoring and training
Risk manager role
Risk management workshops
Process development and documentation
Risk management documentation
This picture describes how events lead to stricter laws and regulations as the public acceptance of risk is continuously lowered over time.Accident – public reaction – legislation to satisfy reduced acceptance of risk.
I would like to start with a short orientation on how the big picture looks in Europe. And there are similar approaches in other parts of the world.The Medical Device Directive sets the overall structure on what has to be done, when developing and manufacturing a medical device.The concept of essential requirements is very central in this system. They have to be fulfilled in your product before its ready for its CE mark.The EU commission defines a number of harmonized standards, that are ”best choices” to fulfill the essential requirements.The standard that we are talking about today, 62304 , is harmonized for Medical Device Directive. It is also harmonized for Active ImplantableMedical Device Directive and In Vitro DiagnosticDevices Directive.To comply to it is voluntary, but in reality it is very hard to claim alternatives to a harmonized standard.
I would like to start with a short orientation on how the big picture looks in Europe. And there are similar approaches in other parts of the world.The Medical Device Directive sets the overall structure on what has to be done, when developing and manufacturing a medical device.The concept of essential requirements is very central in this system. They have to be fulfilled in your product before its ready for its CE mark.The EU commission defines a number of harmonized standards, that are ”best choices” to fulfill the essential requirements.The standard that we are talking about today, 62304 , is harmonized for Medical Device Directive. It is also harmonized for Active ImplantableMedical Device Directive and In Vitro DiagnosticDevices Directive.To comply to it is voluntary, but in reality it is very hard to claim alternatives to a harmonized standard.
POTENTIELL RISK (HAZARD)möjligkälla till SKADA.SKADA (HARM)Händelser i sekvensIsfläck:Hazard: isfläckSequence of events: Jag glömmer hjälmen. Cyklar på en isfläck. Tappar balansen. Slår huvet i backen.Hazardous situation: Jag cyklar på en isfläck utan hjälm.Harm: HjärnskakningRisk: Sannolikhet att få hjärnskakning för jag cyklar omkullSafe design: 4 wheelsRM in device: HelmetRM in process: Aditionaltraining of driverInformation: Warningsign