Quality management with ISO 9001 and/or ISO 13485
The proper functioning of your quality system in compliance with the selected standard, ISO 9001 or ISO 13485, is one of the guarantees of your medical device’s conformity.
WHITE-TILLET advises and assists you in:
- Setting up your quality organization;
- Evaluating the efficiency of its functioning through audits;
- Carrying out audits of reliability outsourcing;
- Developing, in accordance with you, a quality management system that complies with ISO 9001 and/or ISO 13485 standards;
- Being your quality representative with the Authorities (temporarily, for very small businesses).
Tillet Y. Why is quality useful? Doses, May 2003.
Tillet Y. Quality is the mother of Safety and Efficacy. Doses, September 2004.
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