ISO 13485:2016 - Medical devices - A practical guide
Año de publicación: 2017 | Edición: 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.
ISO 13485:2016 - Medical devices - A practical guide
ISO 13485:2016 - Medical devices - A practical guide
pub100422
CHF
96
Convertir Franco suizo (CHF) a tu moneda
Normas relacionadas
- Medical devices — Quality management systems — Requirements for regulatory purposes
- A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.
Esto también le puede interesar
Virtually no medical procedure is without risk, but there are many ways to minimize it. One such way is through applying sound risk management processes to medical devices. The International Standard to …
The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.
The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are …
Más información
Manage quality throughout the life cycle of a medical device with ISO 13485.