This document provides an overview of ISO 13485:2016, which specifies requirements for quality management systems for organizations involved in the life cycle of medical devices. It outlines the scope, purpose and key concepts of the standard. The standard is intended to facilitate alignment with regulatory requirements for quality management in the medical device industry. It is based on ISO 9001 but includes additional requirements specific to medical devices and excludes some non-applicable ISO 9001 requirements.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
This document provides an overview of the key changes between ISO 13485:2003 and ISO 13485:2016 for quality management systems in the medical device industry. It discusses definitions, the timeline for transition, and what is new in each section of the updated standard, including expanded requirements for design and development, purchasing, production, and complaint handling. The changes are aimed at increasing risk-based approaches and ensuring continued compliance with evolving regulations.
This document summarizes ISO 13485:2016, which outlines requirements for quality management systems for organizations involved in the design, development, manufacturing, installation, or servicing of medical devices. It contains 8 clauses that address the scope, documentation requirements, management responsibilities, and other criteria for quality management processes. Organizations that meet the ISO 13485 standard can receive certification to demonstrate their commitment to quality in the medical device industry.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
This document provides an overview of the key changes between ISO 13485:2003 and ISO 13485:2016 for quality management systems in the medical device industry. It discusses definitions, the timeline for transition, and what is new in each section of the updated standard, including expanded requirements for design and development, purchasing, production, and complaint handling. The changes are aimed at increasing risk-based approaches and ensuring continued compliance with evolving regulations.
This document summarizes ISO 13485:2016, which outlines requirements for quality management systems for organizations involved in the design, development, manufacturing, installation, or servicing of medical devices. It contains 8 clauses that address the scope, documentation requirements, management responsibilities, and other criteria for quality management processes. Organizations that meet the ISO 13485 standard can receive certification to demonstrate their commitment to quality in the medical device industry.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
The document provides an overview of key differences between ISO 13485:2016 and ISO 9001:2015 quality management standards for medical devices. ISO 13485 focuses specifically on safety and regulatory requirements for medical devices, while ISO 9001 takes a more general risk-based approach. Some key differences highlighted include ISO 13485 retaining its requirement for documented procedures and a management representative, while ISO 9001 no longer requires these. The document also provides more detail on specific ISO 13485 clauses such as management review, document control, and feedback.
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, DefinitionsArete-Zoe, LLC
This document provides an overview and summary of key changes and requirements in the new Medical Device Regulation (EU) 2017/745, which replaces previous directives. Some of the main changes include expanding the scope of regulated devices, implementing a Unique Device Identifier system for traceability, increasing requirements for clinical evidence and post-market surveillance, and removing grandfathering provisions. The purpose, scope, definitions and objectives are outlined to define the rules for placing medical devices on the EU market while ensuring a high level of safety and performance.
ISO 13485 is an internationally agreed standard that sets out quality management system requirements for organizations involved in the design, production, and servicing of medical devices. It helps ensure medical devices are safe and effective and organizations meet regulatory requirements. The standard was recently revised in 2016 to place a greater emphasis on risk management and align with new quality management practices and regulatory expectations for medical devices and their suppliers. Certification to ISO 13485 can demonstrate an organization's compliance to stakeholders but is not required.
The document discusses ISO 13485:2016 which is an internationally recognized quality management system standard for medical device organizations. It outlines the key requirements for establishing a quality management system including determining processes, documenting procedures, managing documents and records, ensuring management responsibility and review, controlling purchasing and product realization, and conducting internal audits. The standard aims to help organizations consistently meet regulatory requirements and customer needs for medical devices.
This document discusses medical device regulation and classification. It begins by defining medical devices and the purpose of regulation. Devices are classified by invasiveness, duration of use, and anatomical site into Class I, II, and III. Class I devices have the lowest risk, while Class III devices like pacemakers have higher risks. Marketing approval processes vary by class, from general controls for Class I, to 510(k) notifications for Class II that demonstrate substantial equivalence, to stringent Pre-Market Approval (PMA) required for new Class III devices which requires clinical trial data. The document also covers international standards, design control, risk management including failure mode and effect analysis, and risk control methods.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
An overview of ASQ Quality Auditor (CQA) certification program with tips for passing exam
http://seetharamkandarpa.webnode.in/news/web-series-session-1-overview-of-asq-certified-quality-auditor-conducted-on-21-may-2017/
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.
This document provides an overview and explanation of key aspects of ISO 9001:2008, which is an international standard for quality management systems. It discusses what ISO is and what standards are, defines key terms like documents and records, and explains the requirements for quality manuals, procedures, quality policies, objectives, plans, and organization charts outlined in the standard. The document includes examples of templates and checklists that can be used to develop the necessary documentation for an organization's quality management system as specified by ISO 9001:2008.
An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Stan...Greenlight Guru
The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.
The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.
These may include simple reference changes in procedures or revision to production and post-production processes that may be required.
Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard.
TALK TAKEAWAYS:
• A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.
• Reasons for the changes to the latest version
• How to prepare for the coming changes in the standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This document discusses regulatory approval requirements for medical devices. It notes that medical devices must be approved by regulators in over 80 countries worldwide. Key requirements include defining the device and intended use, ensuring safety and effectiveness, and that benefits outweigh risks. Regulatory controls include audits, quality management systems, premarket reviews, postmarket surveillance, and assigning devices to one of four risk classes. The document outlines Cochlear's regulatory approval process, including developing a regulatory strategy and plan, clinical evidence, and generating a Summary Technical Documentation for submission to regulators. It emphasizes that high quality documentation is essential for regulatory approval.
ISO13485 Awareness Training (9-10th November 2021).pptxssuserd5e406
This document provides an overview and summary of the requirements for ISO 13485:2016 quality management systems. It discusses the typical processes required for any company, the system compliance requirements, documentation requirements including the quality manual and medical device file, and management responsibilities such as management review and commitment. Key clauses from ISO 13485:2016 are summarized, including design and development, risk management, and documentation control.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
The document discusses quality audit checklists and their benefits. It explains that checklists help auditors sample key elements of a quality management system in a logical, unbiased way. Checklists also keep the audit focused and reduce workload. The document then provides guidance on creating checklists for adequacy audits to evaluate whether documentation addresses all standard requirements and ensures policy and objective achievement.
ISO: 14971 Quality risk management of medical devicesAtul Bhombe
This document summarizes ISO 14971, the international standard for medical device risk management. It outlines the key aspects of ISO 14971, including the purpose to help manufacturers identify hazards, estimate risks, and implement risk controls. The summary explains the main clauses of ISO 14971 and the overall risk management process of identifying hazards, estimating risks, evaluating and controlling risks, and monitoring risk controls.
Sequence and interaction of qms processesJorge Torres
This document outlines the key quality management system processes and requirements for medical device manufacturers as defined in ISO 13485, including design and development, production and process controls, monitoring and measurement, customer feedback and complaints, regulatory reporting, management responsibility, resource management, and quality improvement. It covers all stages of product realization from design to distribution and includes requirements for documentation, document control, records management, internal auditing, and management review.
This document provides the requirements and guidance for an energy management system (EnMS) based on ISO 50001. It outlines the key components of an EnMS including leadership and commitment, energy policy, planning, support, operation, performance evaluation, and improvement. The standard is intended to enable organizations to establish the systems and processes necessary to improve energy performance, including energy efficiency, use and consumption. Adopting the requirements of this international standard helps organizations manage energy use in a cost-effective manner.
The document provides guidelines for organizations on managing risk. It outlines principles of effective risk management, including creating value, improving performance, and supporting achievement of objectives. It presents a framework with iterative processes for designing, implementing, monitoring, reviewing, and improving risk management. Key components of the framework are leadership and commitment, integration, design, implementation, evaluation, and improvement. The document also describes a process for risk management including communication, scope and criteria, risk assessment, treatment, monitoring and review, and recording and reporting.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
The document provides an overview of key differences between ISO 13485:2016 and ISO 9001:2015 quality management standards for medical devices. ISO 13485 focuses specifically on safety and regulatory requirements for medical devices, while ISO 9001 takes a more general risk-based approach. Some key differences highlighted include ISO 13485 retaining its requirement for documented procedures and a management representative, while ISO 9001 no longer requires these. The document also provides more detail on specific ISO 13485 clauses such as management review, document control, and feedback.
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, DefinitionsArete-Zoe, LLC
This document provides an overview and summary of key changes and requirements in the new Medical Device Regulation (EU) 2017/745, which replaces previous directives. Some of the main changes include expanding the scope of regulated devices, implementing a Unique Device Identifier system for traceability, increasing requirements for clinical evidence and post-market surveillance, and removing grandfathering provisions. The purpose, scope, definitions and objectives are outlined to define the rules for placing medical devices on the EU market while ensuring a high level of safety and performance.
ISO 13485 is an internationally agreed standard that sets out quality management system requirements for organizations involved in the design, production, and servicing of medical devices. It helps ensure medical devices are safe and effective and organizations meet regulatory requirements. The standard was recently revised in 2016 to place a greater emphasis on risk management and align with new quality management practices and regulatory expectations for medical devices and their suppliers. Certification to ISO 13485 can demonstrate an organization's compliance to stakeholders but is not required.
The document discusses ISO 13485:2016 which is an internationally recognized quality management system standard for medical device organizations. It outlines the key requirements for establishing a quality management system including determining processes, documenting procedures, managing documents and records, ensuring management responsibility and review, controlling purchasing and product realization, and conducting internal audits. The standard aims to help organizations consistently meet regulatory requirements and customer needs for medical devices.
This document discusses medical device regulation and classification. It begins by defining medical devices and the purpose of regulation. Devices are classified by invasiveness, duration of use, and anatomical site into Class I, II, and III. Class I devices have the lowest risk, while Class III devices like pacemakers have higher risks. Marketing approval processes vary by class, from general controls for Class I, to 510(k) notifications for Class II that demonstrate substantial equivalence, to stringent Pre-Market Approval (PMA) required for new Class III devices which requires clinical trial data. The document also covers international standards, design control, risk management including failure mode and effect analysis, and risk control methods.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
An overview of ASQ Quality Auditor (CQA) certification program with tips for passing exam
http://seetharamkandarpa.webnode.in/news/web-series-session-1-overview-of-asq-certified-quality-auditor-conducted-on-21-may-2017/
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.
This document provides an overview and explanation of key aspects of ISO 9001:2008, which is an international standard for quality management systems. It discusses what ISO is and what standards are, defines key terms like documents and records, and explains the requirements for quality manuals, procedures, quality policies, objectives, plans, and organization charts outlined in the standard. The document includes examples of templates and checklists that can be used to develop the necessary documentation for an organization's quality management system as specified by ISO 9001:2008.
An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Stan...Greenlight Guru
The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.
The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.
These may include simple reference changes in procedures or revision to production and post-production processes that may be required.
Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard.
TALK TAKEAWAYS:
• A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.
• Reasons for the changes to the latest version
• How to prepare for the coming changes in the standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This document discusses regulatory approval requirements for medical devices. It notes that medical devices must be approved by regulators in over 80 countries worldwide. Key requirements include defining the device and intended use, ensuring safety and effectiveness, and that benefits outweigh risks. Regulatory controls include audits, quality management systems, premarket reviews, postmarket surveillance, and assigning devices to one of four risk classes. The document outlines Cochlear's regulatory approval process, including developing a regulatory strategy and plan, clinical evidence, and generating a Summary Technical Documentation for submission to regulators. It emphasizes that high quality documentation is essential for regulatory approval.
ISO13485 Awareness Training (9-10th November 2021).pptxssuserd5e406
This document provides an overview and summary of the requirements for ISO 13485:2016 quality management systems. It discusses the typical processes required for any company, the system compliance requirements, documentation requirements including the quality manual and medical device file, and management responsibilities such as management review and commitment. Key clauses from ISO 13485:2016 are summarized, including design and development, risk management, and documentation control.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
The document discusses quality audit checklists and their benefits. It explains that checklists help auditors sample key elements of a quality management system in a logical, unbiased way. Checklists also keep the audit focused and reduce workload. The document then provides guidance on creating checklists for adequacy audits to evaluate whether documentation addresses all standard requirements and ensures policy and objective achievement.
ISO: 14971 Quality risk management of medical devicesAtul Bhombe
This document summarizes ISO 14971, the international standard for medical device risk management. It outlines the key aspects of ISO 14971, including the purpose to help manufacturers identify hazards, estimate risks, and implement risk controls. The summary explains the main clauses of ISO 14971 and the overall risk management process of identifying hazards, estimating risks, evaluating and controlling risks, and monitoring risk controls.
Sequence and interaction of qms processesJorge Torres
This document outlines the key quality management system processes and requirements for medical device manufacturers as defined in ISO 13485, including design and development, production and process controls, monitoring and measurement, customer feedback and complaints, regulatory reporting, management responsibility, resource management, and quality improvement. It covers all stages of product realization from design to distribution and includes requirements for documentation, document control, records management, internal auditing, and management review.
This document provides the requirements and guidance for an energy management system (EnMS) based on ISO 50001. It outlines the key components of an EnMS including leadership and commitment, energy policy, planning, support, operation, performance evaluation, and improvement. The standard is intended to enable organizations to establish the systems and processes necessary to improve energy performance, including energy efficiency, use and consumption. Adopting the requirements of this international standard helps organizations manage energy use in a cost-effective manner.
The document provides guidelines for organizations on managing risk. It outlines principles of effective risk management, including creating value, improving performance, and supporting achievement of objectives. It presents a framework with iterative processes for designing, implementing, monitoring, reviewing, and improving risk management. Key components of the framework are leadership and commitment, integration, design, implementation, evaluation, and improvement. The document also describes a process for risk management including communication, scope and criteria, risk assessment, treatment, monitoring and review, and recording and reporting.
This document provides the requirements for quality management systems. It outlines the requirements in 10 sections including leadership, planning, support, operation, performance evaluation, and improvement. The standard is based on quality management principles including customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. Organizations can meet customer requirements and improve performance by following this process approach and utilizing the Plan-Do-Check-Act cycle.
Tiêu chuẩn ISO 14644 cho phòng sạch phần 14: đánh giá tính phù hợp để sử dụng thiết bị bằng nồng độ hạt trong không khí. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Tiêu chuẩn ISO 14644 cho phòng sạch phần 1: phân loại mức độ sạch dựa trên nồng độ tiểu phân. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Eurotherm manufactures temperature sensors, process controllers, power controls, SSR, SCR, and thermowells for process temperature measurement and control. This product guide summarizes the company's US product offering.
This document provides a summary of an ISO standard for information security management systems. It outlines the requirements for establishing, implementing, maintaining and improving an information security management system. This includes understanding the organization's context, leadership involvement, planning security actions, supporting the system through resources and training, operating security controls, evaluating performance, and pursuing improvement. The standard is designed to help organizations manage information security risks and meet the expectations of interested parties through an effective management system.
www.envimart.vn - ĐT: 028 77727979 - sales@envimart.vn - Nền tảng cung cấp thiết bị, vật tư ngành nước và môi trường. Chuyên cung cấp vật tư cho dự án xử lý nước sạch, nước thải và môi trường. Envimart luôn đồng hành, tin cậy với đối tác nhà thầu, nhà tích hợp và người sử dụng.
This document provides guidelines for ensuring user safety, product quality, and machinery reliability in industrial control systems. It covers relevant topics such as energies and safety, the control system, the control model, the user interface, and the MES network. The guidelines reference international standards and are intended to help integrate modules like actuators, stations, and machines into production lines in a way that follows machinery directives and good automation practices.
www.envimart.vn - ĐT: 028 77727979 - sales@envimart.vn - Nền tảng cung cấp thiết bị, vật tư ngành nước và môi trường. Chuyên cung cấp vật tư cho dự án xử lý nước sạch, nước thải và môi trường. Envimart luôn đồng hành, tin cậy với đối tác nhà thầu, nhà tích hợp và người sử dụng.
Vss wht paper sustainable sox c ompliance made easyLaurie LeBlanc
The document discusses sustainable compliance with the Sarbanes-Oxley Act (SOX) using automated tools. It provides an overview of SOX and its impact on IT. It then reviews past compliance efforts and new guidance from the SEC and PCAOB aimed at reducing costs. This includes allowing benchmarking of automated controls to reduce unnecessary testing. The document promotes achieving sustainable compliance by integrating controls and using technology for continuous monitoring and improvement.
This document summarizes an industrial textile technology company that specializes in laser marking, indigo dyeing automation, and ozone treatment systems. The company has over 20 years of experience developing innovative technologies. It prides itself on bringing personalized solutions to customers and has received numerous awards for its technological achievements. The company is committed to effective customer service and continuous research and development to improve productivity and quality for customers.
This document provides guidelines for auditing management systems. It covers managing an audit program, including establishing objectives, determining risks and resources, implementing the program, and monitoring and reviewing the program. It also covers conducting individual audits, including initiating the audit, preparing, performing and completing audit activities, and conducting any necessary follow-up. The document establishes principles and provides guidance on competence and evaluation of auditors.
This document provides operating instructions for the ULTRAMAT 23 gas analyzer. It includes information on safety, installation, technical description, start-up, operation, and maintenance. The ULTRAMAT 23 is an infrared gas analyzer that can measure concentrations of various gases and oxygen. It features automated calibration, data logging and output, and integration capabilities. Installation involves gas and electrical connections following guidelines. Start-up involves an autocalibration procedure and optional calibration. The analyzer operates in warm-up, measuring, and input modes controlled from the display and keypad. Maintenance includes periodic checks and cleaning or replacement of components.
This document provides instructions for the Gene Pulser Xcell electroporation system. It describes unpacking and setting up the system, which includes a main unit and optional modules. The document outlines operating instructions, electroporation protocols for bacterial and fungal cells, and specifications. Safety information is provided, noting the system produces high voltages and currents and should only be operated according to instructions to avoid electrical or mechanical hazards.
This document is a user's guide for the Daily QA 3 device and software. It provides instructions on setting up the hardware and software, performing calibrations, creating templates and test plans, taking measurements, and printing/exporting reports. It also covers maintenance, troubleshooting, specifications, and a regulatory supplement. The Daily QA 3 is a device that measures radiation beam characteristics daily to monitor linac output and detect changes over time through trend analysis.
This document is a user's guide for the Daily QA 3 device and software. It provides instructions on setting up the hardware and software, performing calibrations, creating templates and test plans, taking measurements, and printing/exporting reports. It also covers maintenance, troubleshooting, specifications, and a regulatory supplement. The Daily QA 3 is a device that measures radiation beam characteristics daily to monitor linac output and detect changes over time through trend analysis.
This document provides a technical specification for physical channels and modulation in E-UTRA, also known as LTE. It describes the frame structure, uplink transmission including physical channels like PUSCH and PUCCH, reference signals, and random access. The document also covers downlink transmission with physical channels and signals. It is a specification developed by 3GPP for the LTE wireless communication standard.
The document discusses photometry, which is the science of measuring human visual response to light. It describes how the Commission Internationale de l'Eclairage (CIE) defined the average human eye's response to light in 1924 by compiling data on light-adapted eyes into the photopic curve. The photopic curve shows that people are most sensitive to green light and less sensitive to red and violet wavelengths. The CIE also defined the scotopic curve to describe the eye's response in low-light conditions. The CIE aimed to establish a standard light source as a reference for photometry measurements.
This document discusses predictive maintenance and how to develop predictive maintenance algorithms using MATLAB. It defines predictive, preventative, and reactive maintenance. It then outlines the steps to develop a predictive algorithm, including acquiring sensor data, preprocessing the data, identifying condition indicators, training a model, and deploying the model. It provides examples of developing algorithms for fault classification and remaining useful life estimation using sensor data from a triplex pump.
Similar to ISO 13485-2016 - Medical Devices.pdf (20)
English Drug and Alcohol Commissioners June 2024.pptxMatSouthwell1
Presentation made by Mat Southwell to the Harm Reduction Working Group of the English Drug and Alcohol Commissioners. Discuss stimulants, OAMT, NSP coverage and community-led approach to DCRs. Focussing on active drug user perspectives and interests
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...Media Logic
When it comes to creating marketing strategies that target older adults, it is crucial to have insight into their media habits and preferences. Understanding how older adults consume and use media is key to creating acquisition and retention strategies. We recently conducted our seventh annual survey to gain insight into the media preferences of older adults in 2024. Here are the survey responses and marketing implications that stood out to us.
Test bank clinical nursing skills a concept based approach 4e pearson educati...rightmanforbloodline
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVedanta A
Air Ambulance Services In Rewa works in close coordination with ground-based emergency services, including local Emergency Medical Services, fire departments, and law enforcement agencies.
More@: https://tinyurl.com/2shrryhx
More@: https://tinyurl.com/5n8h3wp8
Health Tech Market Intelligence Prelim Questions -Gokul Rangarajan
The Ultimate Guide to Setting up Market Research in Health Tech part -1
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
This lays foundation of scoping research project what are the
Before embarking on a research project, especially one aimed at scoping and defining parameters like the one described for health tech IT, several crucial considerations should be addressed. Here’s a comprehensive guide covering key aspects to ensure a well-structured and successful research initiative:
1. Define Research Objectives and Scope
Clear Objectives: Define specific goals such as understanding market needs, identifying new opportunities, assessing risks, or refining pricing strategies.
Scope Definition: Clearly outline the boundaries of the research in terms of geographical focus, target demographics (e.g., age, socio-economic status), and industry sectors (e.g., healthcare IT).
3. Review Existing Literature and Resources
Literature Review: Conduct a thorough review of existing research, market reports, and relevant literature to build foundational knowledge.
Gap Analysis: Identify gaps in existing knowledge or areas where further exploration is needed.
4. Select Research Methodology and Tools
Methodological Approach: Choose appropriate research methods such as surveys, interviews, focus groups, or data analytics.
Tools and Resources: Select tools like Google Forms for surveys, analytics platforms (e.g., SimilarWeb, Statista), and expert consultations.
5. Ethical Considerations and Compliance
Ethical Approval: Ensure compliance with ethical guidelines for research involving human subjects.
Data Privacy: Implement measures to protect participant confidentiality and adhere to data protection regulations (e.g., GDPR, HIPAA).
6. Budget and Resource Allocation
Resource Planning: Allocate resources including time, budget, and personnel required for each phase of the research.
Contingency Planning: Anticipate and plan for unforeseen challenges or adjustments to the research plan.
7. Develop Research Instruments
Survey Design: Create well-structured surveys using tools like Google Forms to gather quantitative data.
Interview and Focus Group Guides: Prepare detailed scripts and discussion points for qualitative data collection.
8. Sampling Strategy
Sampling Design: Define the sampling frame, size, and method (e.g., random sampling, stratified sampling) to ensure representation of target demographics.
Participant Recruitment: Plan recruitment strategies to reach and engage the intended participant groups effectively.
9. Data Collection and Analysis Plan
Data Collection: Implement methods for data gathering, ensuring consistency and validity.
Analysis Techniques: Decide on analytical approaches (e.g., statistical
Solution manual for managerial accounting 18th edition by ray garrison eric n...rightmanforbloodline
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Digital Health in India_Health Informatics Trained Manpower _DrDevTaneja_15.0...DrDevTaneja1
Digital India will need a big trained army of Health Informatics educated & trained manpower in India.
Presently, generalist IT manpower does most of the work in the healthcare industry in India. Academic Health Informatics education is not readily available at school & health university level or IT education institutions in India.
We look into the evolution of health informatics and its applications in the healthcare industry.
HIMMS TIGER resources are available to assist Health Informatics education.
Indian Health universities, IT Education institutions, and the healthcare industry must proactively collaborate to start health informatics courses on a big scale. An advocacy push from various stakeholders is also needed for this goal.
Health informatics has huge employment potential and provides a big business opportunity for the healthcare industry. A big pool of trained health informatics manpower can lead to product & service innovations on a global scale in India.
The Ultimate Guide in Setting Up Market Research System in Health-TechGokul Rangarajan
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
"Market Research it too text-booky, I am in the market for a decade, I am living research book" this is what the founder I met on the event claimed, few of my colleagues rolled their eyes. Its true that one cannot over look the real life experience, but one cannot out beat structured gold mine of market research.
Many 0 to 1 startup founders often overlook market research, but this critical step can make or break a venture, especially in health tech.
But Why do they skip it?
Limited resources—time, money, and manpower—are common culprits.
"In fact, a survey by CB Insights found that 42% of startups fail due to no market need, which is like building a spaceship to Mars only to realise you forgot the fuel."
Sudharsan Srinivasan
Operational Partner Pitchworks VC Studio
Overconfidence in their product’s success leads founders to assume it will naturally find its market, especially in health tech where patient needs, entire system issues and regulatory requirements are as complex as trying to perform brain surgery with a butter knife. Additionally, the pressure to launch quickly and the belief in their own intuition further contribute to this oversight. Yet, thorough market research in health tech could be the key to transforming a startup's vision into a life-saving reality, instead of a medical mishap waiting to happen.
Example of Market Research working
Innovaccer, founded by Abhinav Shashank in 2014, focuses on improving healthcare delivery through data-driven insights and interoperability solutions. Before launching their platform, Innovaccer conducted extensive market research to understand the challenges faced by healthcare organizations and the potential for innovation in healthcare IT.
Identifying Pain Points: Innovaccer surveyed healthcare providers to understand their difficulties with data integration, care coordination, and patient engagement. They found widespread frustration with siloed systems and inefficient workflows.
Competitive Analysis: Analyzed competitors offering similar solutions in healthcare analytics and interoperability. Identified gaps in comprehensive data aggregation, real-time analytics, and actionable insights.
Regulatory Compliance: Ensured their platform complied with HIPAA and other healthcare data privacy regulations. This compliance was crucial to gaining trust from healthcare providers wary of data security issues.
Customer Validation: Conducted pilot programs with several healthcare organizations to validate the platform's effectiveness in improving care outcomes and operational efficiency. Gathered feedback to refine features and user interface.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.