Iso 14971 2019
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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.
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ISO: 14971 Quality risk management of medical devices
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.
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ISO: 14971 Quality risk management of medical devices
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.
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[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
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Rights of Auditee
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How to Handle an Audit Session?
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Iso13485 ppt
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
Medical Devices Regulation (MDR) 2017/745 - Postmarket surveillance
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MDD 93/42/EEC
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
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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.
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The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
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Author:Susan Gardner, PhD
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[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
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Rights of Auditee
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Auditee's Conduct
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Clinical investigation and evaluation of medical devices and ivd.pptx
This document discusses clinical investigation and evaluation of medical devices and in vitro diagnostics (IVDs). It defines medical devices and IVDs, describes their classification systems, and explains when clinical investigations and evaluations are needed. Clinical investigations generate safety and performance data, while evaluations assess existing data. The document outlines ethical considerations and describes the stages and reports involved in clinical investigations and evaluations.
Iso13485 ppt
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
Medical Devices Regulation (MDR) 2017/745 - Postmarket surveillance
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see more https://www.aretezoe.com/medical-devices
International Medical Device Regulators Forum
The document summarizes the International Medical Device Regulators Forum (IMDRF), which was established in 2011 to accelerate international harmonization of medical device regulations. It provides background on IMDRF's establishment and membership, which includes regulators from 11 countries and regions. The document also discusses IMDRF's relationship to the prior Global Harmonization Task Force (GHTF) and describes IMDRF's management structure, meetings, and current working groups on issues like adverse event terminology and medical device cybersecurity.
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ISO 13485.pptx
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.
MDD 93/42/EEC
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
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This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
Medical devices
The document defines medical devices and their classification according to various regulatory bodies. It begins by defining a medical device as any instrument intended for internal or external use in the diagnosis, treatment, or prevention of disease. It then discusses the classification of devices by the US FDA, CDSCO, and the European Union as Class I, II, or III based on increasing risk levels. The document provides examples of devices that fall into each class and outlines the regulatory processes, including premarket approval or clearance, that manufacturers must go through for devices in each class to be legally marketed.
regulatory aspects of medical devices in USA
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
The regulation of IVD medical devices
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
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This document provides an overview of quality risk management. It defines key terms like risk, hazard, risk assessment, and risk management. It describes the ICH guidelines related to quality risk management and explains the scope, principles, flow chart, and tools of quality risk management. The tools discussed include FMEA, FMECA, FTA, HACCP, and basic risk management methods. The document aims to introduce the topic of quality risk management.
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This document provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on quality risk management. It defines key terms like harm, hazard, risk, severity and quality risk management. The document outlines the general quality risk management process which includes risk assessment, risk control, communication and review. It describes the principles of quality risk management and provides examples of tools that can be used in the risk assessment process like Failure Mode and Effects Analysis, Hazard Analysis and Critical Control Points, and Fault Tree Analysis.
Medical Product Development cycle
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.
Risk managements documents required for the market placement of a medical dev...
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
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Quality risk management
This document discusses quality risk management as outlined in the ICH Q9 guideline. It provides an introduction to quality risk management, including definitions of risk and management. It then describes the general quality risk management process, which involves responsibilities, initiating a risk assessment, risk assessment, risk control, risk communication, and risk review. Finally, it discusses various risk management tools and methods and provides potential applications of quality risk management in different aspects of the pharmaceutical quality system.
8.RiskManagement.ppt
This document summarizes ISO 14971, which provides a framework for medical device manufacturers to systematically manage risks. It outlines the risk management process, including risk analysis, evaluation, control, and monitoring effectiveness. Key terms like harm, hazard, risk and risk assessment are defined. Manufacturers must establish a risk management plan and file to document risks identified and ensure traceability of risk control measures.
ICH Guidelines for Pharmacovigilance.pdf
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Risk Management Presentation Public
This document discusses effective risk management for medical devices. It outlines standards like ISO 14971 and FDA guidance on applying risk management. The key aspects of risk management include planning, analysis, evaluation, control, and reporting. Various risk analysis techniques are described like hazard analysis, FMEA, and fault tree analysis. Risk controls and tracing risks to test cases are also covered. The importance of ongoing risk management after development is emphasized, as is taking a proactive rather than reactive approach to ensure patient safety and compliance.
Risk management in development of life critical systems
The document discusses risk management best practices for developing life critical systems and medical devices. It defines key safety concepts like hazards, risks, and failures. It recommends performing risk analysis early in development using methods like FMEA. It also advocates for model-driven development practices like requirements management, system modeling, and automated document generation to improve safety, quality, and compliance. Success stories are provided of medical device companies using IBM Rational solutions to develop smarter and safer products.
Risk management in pharmaceutical Industry
This document provides an overview of risk management in the pharmaceutical industry. It discusses the objectives, scope, definitions, and tools used in risk management. The key tools covered include Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), and Preliminary Hazard Analysis (PHA). The goal of risk management is to identify potential risks, evaluate their likelihood and impact, and develop control measures to mitigate risks and ensure product quality and safety.
Session 05_Risk Assessment Program for YSP_Risk Analysis II
Program Objectives
In light of industrialization trends across the globe, new hazards are constantly introduced in many workplaces. This program aims to provide Young Safety Professionals (YSPs) from diverse backgrounds with the requisite skill to address the health and safety hazards in the modern workplace.
Hazard and Risk Management
HAZARD AND RISK MANAGEMENT IN INDUSTRY INCLUDING ICH GUIDELINES FACTORY ACT AND RULES PHYSICOCHEMICAL MEASUREMENT OS EFFLUENT, BOD, COD
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Iso 14971 2019
- 1. ISO 14971 This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls
- 2. Risk Management and RMF The intent behind Risk Management is to identify, evaluate, analyze, assess, and mitigate potential product issues. The process itself includes: • Risk Management Planning • Risk Analysis • Risk Evaluation • Risk Controls • Overall Residual Risk Acceptability • Risk Management Review • Production & Post-Production Information
- 3. Risk Management • Risk :- Combination of the probability of occurrence of harm or severity of that harm. • Considering the complexity of medical device design, focused risk management practices help ensure usability, safety, and regulatory compliance. It is a process of identifying, controlling and preventing the failure that may cause hazards to user
- 4. FMEA
- 5. FMEA Table
- 6. Severity
- 7. Occurrence
- 8. Detection
- 9. RPN Number
- 10. FMEA Table with control methods and actions FMEA example
- 11. Other Major ISO Standards IEC 60601-1 : Regulations for Electrical and Electronic medical devices. ISO 14001 : Environmentsl Management ISO/IEC 27001 : Buisness continiutity ISO 45001 : Information security. ISO 22000 : Food safety. ISO 9001 : Quality mangement[similar to ISO 13485] ISO 20000-1 : Service Management. ISO 55001 : Asset management. ISO 10002 : Customer satisfaction and complience handling CE marking for European market.
- 12. Thank you !