The FDA's Quality System Regulation (21 CFR Part 820) requires that "Design validation shall include...risk analysis". In addition, a FDA Reviewer's Guidance requires that a Hazard Analysis be completed and included for the approval of 510(k) submissions. The new ISO 13485:2016 requires Risk Management throughout the quality system. ISO 13485 specifically recommends that ISO 14971 be used when managing risk; which is required when obtaining a CE Mark. Lack of a comprehensive Risk Management program will likely result in inspection and submission problems; as well as, possible enforcement actions. Risk management and ISO 14971 has also become very important and a hot topic when complying with IEC 60601-1 3rd Edition. This seminar provides a complete overview of the principles of risk management for device manufacturers to comply with FDA and International regulations, including ISO 14971, IEC 60601-1 3rd Edition, EN ISO 14971:2012 Annex Z, AAMI/ISO TIR 24971, and other new international guidance and standards. EN ISO 14971:2012 Annex Z has caused a lot of controversy regarding how companies should deal with risk reduction by eliminating the ALARP approach and going to "Reduced as far as possible" approach...we will be discussing this topic. The Risk Analysis methods reviewed may be applied to all aspects of Medical Device Design and Manufacturing including; mechanical, electronic, microprocessor, software, & disposable products and manufacturing processes; as well as, in other areas of the Quality System. All attendees will receive templates for Risk Analysis, Fault Trees, FMECA & more. FDA and new International Standards for risk management, risk analysis, risk assessment, and system safety will be discussed.
What you will learn:
- How to comply with FDA's Design Control requirement for risk
- How to comply with FDA's requirement for hazard analysis
- Understand the impact of EN ISO 14971:2012 Annex Z
- FDA regulations & ISO 13485 requirements (including ISO 13485:2016) for Risk Management & Hazard Analysis.
- Understand ISO 14971 and how to implement to comply with FDA & ISO/EN requirements.
- Differences between Risk Management, Risk Assessment and Hazard Analysis.
- Methods of documentation for Risk Analysis & FMEA.
- When to perform Risk Analysis in the Product Life Cycle.
- Top-down Fault Tree Analysis (FTA).
- Bottom-up Failure Modes and Effects Analysis (FMEA).
- How to determine which parts of your product need FMEA.
- Risk Analysis as part of software verification and validation.
- How to identify potential hazards or sources of harm.
- How to estimate probability of risk and degree of severity.
- How to use Hazard Analysis & Risk Management to improve
- Generating Critical Components and Critical Process Lists.
- Fail-safe design techniques and software/hardware trade-off strategies.
Benefits of Attending:
- Be prepared for an FDA Design Control inspection or ISO 13485 audit
- Conformance to FDA & International requirements for Risk
- Implementation of Risk Management for 510(k), IDE, PMA, and CE Mark submissions
- Understand the new EN ISO 14971 Annex Z for handling residual risk
- Faster approvals & compliance with U.S. & International
- Reduced Product Liability and Recall risks
- Reduced Re-design and Quality Costs
- Increased Competitiveness with safer products and faster approvals
- Earlier management awareness of potential design pitfalls
- A. U.S. FDA compliance regulations for Risk Management
- B. International/ISO/European Standards impacting Medical Device Design & Safety including: ISO 14971, ISO 13485:2016, Medical Device Directive, IEC 60601-1 3rd Edition, GHTF guidance, AAMI/ISO TIR 24971and EN ISO 14971:2012 (Z Annex)
- C. Risk Management and the Product Life Cycle
- D. Identifying Hazardous Conditions and Sources of Harm
- E. Estimating Probability and Degree of Severity
- F. Failure Modes and Effects Analysis (FMEA), Process FMEA and HACCP
- G. The Top-Down Approach: Fault Tree Analysis (FTA)
- H. The Bottom-Up Approach: Failure Mode Effects Criticality
- I. Disposable & Consumable Medical Device Risk Analysis Techniques and Process FMEA & HACCP
- J. Software & Microprocessor-Controlled System Hazard
- K. How to Package Risk and Hazard Analysis for 510(k), PMA,
IDE & CE Mark submissions
- L. Risk Management in the Quality System
- M. Review and Summary
Speakers: David MacKenzie, Dennis Rubenacker