Medical Device Risk Management

precon

8:00 a.m. – 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. – 10:00 a.m.

Part A – Concepts of Risk Management

  • Introduction
  • Fundamentals of Risk Management
  • Components of Risk and Problems to Consider
  • Analyzing an EtO Explosion
  • Definitions from ISO 14971:2007
  • Assessing Risk Using the Definition
  • FMEA is Not Risk Management

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Part B – The Regulatory Framework

  • ISO 14971:2007 as the International Standard
  • National and Regional Variations (US, Canada, EU)
  • Risk Management in FDA QSR
  • Risk Management in ISO 13485:2016
  • CMDCAS and MDSAP
  • EU Standards
  • Canadian Standards
  • Global Harmonization Task Force Guidance
  • FDA Warning Letters – Learning from Others

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part C – ISO 14971:2017 Overview

  • The Structure of the Standard
  • The Process Flow in ISO 14971:2007
  • Setting Risk Acceptability Criteria
  • Hazard Analysis, not FMEA, as the Primary Tool

Part C1 – The PFMEA Relationship

  • FMEA is NOT Risk Management
  • Hazard Analysis and Communication with the PFMEA
  • Detectability, RPNs, and Related Issues

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Part D1 – Implementing EN ISO 14971:2012

  • The Process Flow in EN ISO 14971:2012
  • The Risk Management File
  • The Risk Management Plan
  • Evaluating Personnel Qualification
  • Using Product Safety Standards
  • Risk Analysis
  • Risk Evaluation
  • Risk Control
  • Application Examples – Powered Toothbrushes
  • Information for Safety vs. Disclosure of Residual Risk
  • Disclosing Residual Risk
  • Risk/Benefit Analysis

4:30 p.m.

Session Wrap-up, End of Day One

 

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