How to estimate risk for a medical device according to ISO 14971:2019 скачать в хорошем качестве

How to estimate risk for a medical device according to ISO 14971:2019

This is an excerpt from the course "Introduction to risk management for medical devices and ISO 14971:2019" which is available at: https://medicaldevicehq.com/iso14971 Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link: https://medicaldevicehq.com/templates/ We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns. NB. at 11:14, the video shows an incorrect calculation; 100%*0,1%=0,01%, which is obviously not correct. It should be 100%*0,1%=0,1%. Chapters: 00:00 Introduction 00:23 About the instructor 01:07 An overview of the hazard traceability matrix 01:33 Why you should document risk control measures 04:03 The definition of risk according to ISO 14971 04:46 How to estimate the probability of occurrence of harm 07:37 How to estimate risk in medical device development 09:11 Probability of occurrence of harm vs. probability of occurrence of a hazardous situation 10:47 What is the P1, P2 and Po? 13:37 Additional help and resources 14:03 The most common medical device development mistakes