How to Estimate Risk

The most common question I get when delivering courses on risk management and ISO 14971:2019 is how you should be estimating risk. It is something that many of us have to do when we take part in risk management. I will share with you how it’s supposed to be done, and...

What is new in ISO 14971:2019

 in tAs you may know, in December 2019, the new updated version of the ISO 14971 was released. What does this update mean to you? Use this free checklist if you need help going over your own procedures and documents for the update. This video is an extract from the...

FMEA vs ISO 14971

Many medical device manufacturers are working with FMEA. The concern is, does FMEA meet the regulatory requirements as to mark? Is FMEA the same as risk analysis? Or even risk management according to ISO 14971? This video is an extract from the online course Risk...