ISO recently released a new handbook named "ISO 13485:2016 – Medical devices – A practical guide," which was written by a group of technical experts from ISO's technical committee ISO/TC 210 ...

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on.

ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices, replaces the 1999 edition.

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (ONLINE EVENT: March 13, 2025) - ResearchAndMarkets.com ...

A Many foreign countries are now requesting medical device firm's supply them proof of certification to ISO 13485:2003. To apply a CE mark under the Medical Device Directive, 93/42/EEC, certification ...

In February 2016 the International Standards Organization (ISO) revised its medical device standard, ISO 13485:2003 to ISO 13485:2016, placing greater emphasis on medical device quality management ...

Notes Medical Devices; Quality System Regulation Amendments, 89 Fed. Reg. 7496 (February 2, 2024), which is to be codified at 21 CFR Part 820 and Part 4.

Over the last 15 years, ISO 10993-18 has become a notable resource for professionals at each stage in the supply chain and manufacturing of medical devices, assisting them in the evaluation of ...