Скачать с ютуб Risk management for medical devices and ISO 14971 - Online introductory course в хорошем качестве

Risk management for medical devices and ISO 14971 - Online introductory course

This is an online short course on Risk Management for Medical Devices and ISO 14971:2019. It also includes a comparison between ISO 14971 risk management and FMEA. The course is great for onboarding employees, and the participant will receive a course certificate upon completion. The full Introduction to Risk Management and ISO 14971 online course can be found here: https://medicaldevicehq.com/online-co... 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. Chapters 00:00 About the instructor 00:24 Introduction to this short course 00:41 Learning goals of this short course 01:14 Implementing an ISO 14971 risk management process 01:31 Creating a safe medical device 02:01 The ISO 14971 definition of safety 02:53 What is risk management for medical devices? 03:23 An overview of the risk management process 04:17 Risk management is a requirement in the US and the EU 05:03 The risk management process from start to end 07:18 The ISO 14971 definition of risk 07:31 Estimating the probability of occurrence of harm (Po) 08:36 Risk control options analysis 08:58 Risk control measures 09:21 Verification of effectiveness 10:03 Implementation of risk controls 10:28 Estimating the residual risk 11:16 Risk management review and the risk management file 12:39 Production and post-production activities 13:54 An overview of the FMEA 14:30 ISO 14971 risk management vs. IEC 60812 FMEA 16:16 Additional help and resources