Risk Analysis of Medical Devices

Date: 23rd November 2020 -
27th November 2020
Time: 10:00 - 12:30
Duration: 5 virtual sessions
Venue: Online
Event details:

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







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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.

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Per delegate: €440.00
(plus VAT)
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