Risk Management, ISO 14971 & FDA Requirements
Risk Management, ISO 14971 & FDA Requirements
(On-site or Virtual Private Group/Company Training)
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Location: On-site or Virtual
Who: Your entire company, department, project team, you select
- How to comply with FDA's Design Control requirement for risk analysis.
- How to comply with FDA's requirement for hazard analysis for submissions.
- Understand the impact of new ISO 14971:2019, and the new AAMI/ISO TIR 24971.
- 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 / MDR / IVDR requirements.
- How to implement Risk Management as part of Design Control.
- 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).
- Usability and Risk considerations.
- 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 system safety.
- Generating Critical Components and Critical Process Lists.
- Fail-safe design techniques and software/hardware trade-off strategies.
- Be prepared for an FDA Design Control inspection or ISO 13485 audit
- Conformance to FDA & International requirements for Risk Management
- Implementation of Risk Management for 510(k), IDE, PMA, and CE Mark submissions
- Understand the impact of ISO 14971:2019 & AAMI/ISO TIR 24971
- Understand the new ISO 14971 for handling residual risk
- Faster approvals & compliance with U.S. & International agencies
- 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: New ISO 14971:2019, ISO 13485:2016, Medical Device Directive, IEC 60601-1 3rd Edition, GHTF guidance, and AAMI/ISO TIR 24971
- 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 Analysis (FMECA)
- I. Disposable & Consumable Medical Device Risk Analysis Techniques and Process FMEA & HACCP
- J. Software & Microprocessor-Controlled System Hazard Analysis
- 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
Overview:
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 14971:2019 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 New ISO 14971:2019, IEC 60601-1 3rd Edition, AAMI/ISO TIR 24971, and other new international guidance and standards. There has been 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:
Benefits of Attending:
Abbreviated Outline:
Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.
Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.
Request a training proposal for your company.