Risk Management applied to Medical Devices (ISO 14971:2007)

European and American Regulations for Medical Devices present Risk Management as an essential element of the product file and of associated processes. However in these documents, only broad lines of the methodology to apply are described. Few practical information are given on tools and techniques that may be used but ISO 14971:2007 is referenced as the main guidance to follow for Risk Management. This training course allows going through regulatory requirements, ISO 14971 content and requirements, and available risk analysis methods; Then applying the principles defined in a Risk Management adapted to the Devices design and manufactured in your company.

 Know European and FDA regulatory and standards requirements.

 Know why Risk Analyses are necessary.

 Know ISO 14971:2007 requirements and the differences with 2000 version.

 Know the terminology used in Risk Management.

 Know the concepts linked to Risk Management.

 Know the main Risk Analysis techniques.

 Know which type of Risk Analysis to use according to the intended goal.

 Acquire a pragmatic Risk Analysis methodology.

 Know how to define Risk Management methods.

1. Stakes, Standards, and Regulations

Overview of major texts regarding Risk Management and Medical Devices. FDA and European approaches regarding Risk Management. What are the regulatory requirements for Risk Management? Why Risk Management is necessary in Medical Devices?

2. Definitions

Reminder of Risk Management terminologies. Difference between « deductive » and « inductive », « qualitative » and « quantitative », « process » and « functional », as well as between « harm », « hazard » and « risk », « cause » and « error » …

3. ISO 14971:2007

Presentation of ISO 14971:2007 « Application of Risk Management to Medical Devices » : content and main requirements. Detailed review of ISO 14971:2007 main chapters. Differences between 2007 version and 2000 version.

4. Risk Management Theory
Concepts behind Risk Management. Terminologies used in Risk Management. Prerequisites to any Risk analysis. How to perform a Risk Analysis. Know how to determine key points to successfully perform a risk Analysis: Team building, choice of references and perimeter, determination of assessment scales. Content of a Risk Analysis. How a Risk analysis takes place?

5. Risk Management Process

Risk Analysis. Risk Evaluation. Risk Control. Evaluation of overall residual risk acceptability. Risk Management Report. Production and post-production Information.

6. Risk Analysis Techniques

Presentation of the different types of Risk Analysis Techniques (deductive, inductive…). Detailed presentation of the main Techniques, of their advantages and inconvenient, of their application: Ursache-Wirkungs-Diagramm - Cause-Effect Diagram - FMEA / FMECA - HAZOP - Fault Tree Analysis - CVO-RM - HACCP Presentation of the Product Risk Analysis approach. Presentation of the Process Risk Analysis approach.


PRACTICAL CASE STUDY

Which type(s) of Risk analysis to use in your company? Determination of analysis Criteria (Severity, Occurrence, Detection, Others). Determination of Risk Assessment Methods and Risk Management Methods. Practical case study: Risk Analysis on actual examples.

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.