As legal manufacturer – according to the law – or as distributor of health products, vigilance is an obligation and a responsibility.
Materiovigilance applies to medical devices after they are placed on the market; except those which are subject to clinical investigations.
The aim of materiovigilance is to avoid that incidents and risks of serious incidents involving medical devices occur or reoccur, by taking preventive and/or appropriate corrective actions. Each legal manufacturer must designate a responsible person and his substitute.
WHITE-TILLET advises and assists you in:
- Managing your materiovigilance file;
- Analyzing complex cases;
- The declarations to the Competent Authorities;
- The representation (qualified person) with the Competent Authorities.
24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France