INTRODUCTION
Risk management plays a pivotal role in ensuring the safety and effectiveness of medical devices, safeguarding patient health, and meeting regulatory requirements. With the increasing complexity of medical technologies and global regulatory expectations, manufacturers must adopt robust risk management practices to identify, analyze, evaluate, and mitigate risks throughout the product lifecycle.
This comprehensive training program focuses on ISO 14971:2019 / EN ISO 14971:2019/A11:2021, the globally recognized standards for medical device risk management. These standards outline a systematic approach to managing risks, integrating safety considerations into the design, production, and post-market phases of medical devices.
Key Features:
- Comprehensive coverage: In-depth understanding of ISO 14971:2019 and EN ISO 14971:2019/A11:2021 requirements.
- Regulatory alignment: Guidance on integrating risk management into quality management systems and meeting regulatory expectations.
- Expert instruction: Delivered by experienced professionals with extensive knowledge of medicaldevice regulations and standards.
Take the first step toward strengthening your risk management expertise and ensuring compliance with global standards. Join us in mastering risk management for medical devices to enhance patient safety and product reliability!
COURSE OBJECTIVES
This training aims to provide participants with a clear understanding and insight into the EN ISO 14971:2019/A11:2021 requirements. The training takes a look at the major changes in the 2019 update/revision and also covers some of the commonly used risk management tools such as FMEA, FTA, etc.
COURSE OUTLINE
1. Introduction
2. Understanding basic principles of risk management
- Standards & regulation
- What is risk management
- The importance of risk management
- When to initiate risk management
- Use of risk management
3. EN ISO 14971:2019/A11:2021 requirements
- Clause 1: Scope
- Clause 2: Normative Reference
- Clause 3: Terms and Definitions
- Clause 4: General Requirements for Risk Management System
- Clause 4.1: Risk Management Process
- Clause 4.2: Management Responsibilities
- Clause 4.3: Competence of Personnel
- Clause 4.4: Risk Management Plan
- Clause 4.5: Risk Management File
- Clause 5: Risk Analysis
- Clause 6: Risk Evaluation
- Clause 7: Risk Control
- Clause 8: Evaluation of Overall Residue Risk
- Clause 9: Risk Management Review
- Clause 10: Production and Post-Production Activities
4. EN ISO 14971:2019 background
5. EN ISO 14971:2019 vs EN ISO 14971:2012 vs EN ISO 14971:2009 vs ISO 14971:2007
6. Differences in the structure and content of ISO 14971:2007 vs ISO 14971:2019
7. Review on EN ISO 14971:2019/A11:2021 Annex Z
8. Highlighted changes in EN ISO 14971:2019 vs EN ISO 14971:2012
9. Changes in ISO / TR 24971:2020
10. Summary of what need to be done to meet EN ISO 14971:2019/A11:2021 requirements
11. Extra information
Zeito Plastic Components Sdn Bhd
www.dexcom.com
