Certification of quality management systems 13485
Voluntary standard for the certification of quality management systems for organizations which design, develop, produce, market, install and service medical devices.
Among the standard`s key requisites:
- a risk analysis developed through an identification, assessment, prevention and reassessment of residual risk approach;
- information to the user;
- management of the non conforming device from the point of view of traceability of the product and of its critical components;
- implementation of company management system.