Free Medical Device Risk Management Course: Introduction & Simple Risk Table (ISO 14971)
Автор: OpenRegulatory
Загружено: 2025-10-14
Просмотров: 114
Описание:
In the first video of our free ISO 14971 risk management course, I'll walk you through how a simple risk analysis would work. We'll start from first principles without reading the standard line by line (boring!).
00:00 Introduction
00:38 Recap of prior documentation (IEC 62304 course)
02:12 Simple risk table (Google Sheets!)
07:49 Risk acceptance
09:17 Risk controls
Check out Formwork, our eQMS software which helps you automate your medical device compliance:
https://openregulatory.com/formwork
Check out the OpenRegulatory website for free medical device compliance templates:
https://openregulatory.com
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