In Europe, the conformity of medical devices according to EEC-decrees 93/42/EEC must be assessed before sale of a medical device is permitted.
The established assessment of a company’s Quality Management System according to ISO 13485:2003 by a Notified Body (such as Nemko) is necessary to obtain a certificate of conformity allowing CE marking and the permission to sell the medical device in the European Union.
How does the certification process work?
The certification process consists of two phases:
- Phase 1 consists of a visit to the business in order to review the status of the organization, system documentation, infrastructure, etc. This assesses the maturity of the quality management system.
- Phase 2 is the certification audit aiming to verify that the system documentation meets the requirements of ISO 13485:2003 standard. The certification audit will give feedback to the organization on issues that are not in conformance with the standard and that needs to be corrected before a certificate can be issued.
Please phone or send us your request in the form below, and we will contact you as soon as possible. Let us know your purpose and we will find the right person to call you back.