Year of publication: 2017 | Edition: 1
ISO 13485:2016 – Medical devices – A practical guide has been authored by technical experts of ISO/TC 210. The handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector, such as manufacturers, importers, distributors, service providers, certification bodies or regulatory bodies, can benefit from this publication.
- Quality management systemsRequirements for regulatory purposes
- A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.