Medical Device Regulation

The pages below contain full notes (and diagrams) as well as summaries (marked as TL;DR) of the listed standard.

ISO 13485:2016 Concepts

ISO 13485 is an important quality management standard for medical device companies not only in the US but also in Europe.

FDA 21 CFR Part 820 – Quality System Regulation (QSR) for Medical Devices

Code of Federal Regulation (CFR) Title 21 (relating to Food and Drug) Part 820 (Quality System Regulation), also know as current Good Manufacturing Practices (cGMP), is a set of Quality Management requirements published by the FDA for FDA-regulated products (foods, drugs, devices, etc.) to ensure the safety and efficacy of the product when it reaches consumers.