Quality Training

Risk Analysis of Medical Devices

Objectives

Content includes

Outcomes:
An appriciation of Requirements of ISO 14971:2019
Where Risk Analysis fits in to the legal framework
Additional requirements imposed by them Medical Device Regulation
Methods of Risk Analysis
An overview of Risk Analysis in other ISO standards
How to continuously update the Risk Analysis in a practical way
Conducting a risk assessment, 
Practical use of, and the limits of, an FMEA
Writing a risk procedure, plan and report
Tying in vigilance and setting limits and trigger points for risk analysis
Relating Post-Market Surveillance to Risk Analysis

Who should attend

For those who are:
Implementing a RISK ANALYSIS to ISO 14971:2019
Involved in ensuring a Risk Analysis meets the requirements of the EU Medical Device Regulation. 
Quality & Regulatory Professionals

Upcoming dates:

No training dates available at the moment.