Risk Analysis of Medical Devices
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.
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
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
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