ISO 14971 2Day

Delivering in-house training in ISO 14971, Medical Devices- Application of Risk Management

Call Rachel McLean +44(0)1292 671555

ISO 14971:2009

Designed and developed for delegates who have an understanding of Hazard & Risk and wish to design, document, develop, improve and maintain their Risk Management Processes and upgrade to the new requirements of the 2007 revision.

Day 1 Course Contents

Review of the Standard & Documentation Requirements

Scope
Definitions
Requirements
- Risk Management Process
- Management Responsibility
- Qualification of Personnel
- Risk Management Plan
- Risk Management File
Risk Analysis
- Risk Analysis Process
- Intended Use /Characteristics Identification
- Identification of Hazards
- Estimation of Risk for Each Hazard / situation
- Risk Evaluation
Risk Control
- Risk Reduction
- Risk Control Options
- Implementation of measures to control Risk
- Residual Risk Evaluation
- Risk / Benefit Analysis
- Risks Arising from Control Measures
- Completeness of Risk Control
Evaluation of Overall Residual Risk Acceptability
Risk Management Report
Production and Post Production Information

Call Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk to discuss your needs.

Day 2 Course Contents

Hazard Analysis Tools & Risk Evaluation

Planning & links to design, process and specification control
Hazard Analysis
- Annex A: Rational for Requirements
- Annex B: Risk Management Process
- Annex C: Device Characteristics
- Annex D: Risk Concepts
- Annex E: Examples of Hazards, Events & Situations
- Annex F: Risk Management Planning
- Annex G: Risk Management Techniques
- Annex I: Risk Analysis for Biological Hazards
Risk Evaluation
- Risk Concepts
- Models / Tools
  - FMEA
Risk Management Report