ISO 13485 - Quality management for medical devices
Year of publication: 2016 | Edition: 1
A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.
en
| Format | Language | |
|---|---|---|
| pub 1 0 | Paper |
- CHF0*
* Shipping costs will be charged
Related Standards
- Medical devicesQuality management systemsRequirements for regulatory purposes
- Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
This may also interest you
Taking the headache out of regulations while improving product safety and performance.
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.
Health for all is the theme of the World Health Organization’s World Health Day, and a new ISO committee recently formed aims to help.
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 …
More information
Manage quality throughout the life cycle of a medical device with ISO 13485.
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)