Global Medical Device Standards
ISO Standards and Guides for the Medical Device Quality System
- ISO 13485:2016- Medical Devices- Quality Management Systems- Requirements
- ISO 15189:2012 – Medical Laboratories – Particular Requirements for Quality and Competence
- ISO 15378:2017 – Quality Management Systems – Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO 9001:2015, with Reference to Good Manufacturing Practice (GMP)
- ISO 9001:2015 – Quality Management Systems Requirements
- ISO 14971:2019 – Medical devices – Application of risk management to medical devices
- ISO Guide 73-2009 – Risk management – Vocabulary
- ISO 16142-1:2016 – Medical Devices – Recognized essential principles of safety and performance of medical devices
- ISO/TS 20993:2006 – Biological Evaluation of Medical Devices – Guidance on a Risk Management Process
US FDA Medical Device Standards, Regulations & Guidelines
- U.S. Food and Drug Administration- Medical Devices
- FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a document that outlines Current Good Manufacturing Practice (CGMP).
- Design Control Guidance for Medical Device Manufacturers Text related to FDA 21 CFR 820.30 and sub clause 4.4 of ISO 9001.
- Labeling for Medical Devices Guidance on medical device labeling from the FDA
- Quality Systems Regulations (QSR) – US FDA QSR regulation and Good Manufacturing Practices (GMP).
- Post Market Surveillance – Guidance on criteria and approaches for medical device post-market surveillance.
- Human Factors in Medical Device Design – Discusses the CDRH push to have manufacturers apply Human Factors to device design.