Get your
Medical Device QMS
from the Experts
Fully compliant to ISO 13485:2016
Why a Quality Management System?
- Process implementation required by MDR 2017/745 and IVDR 2017/746
- Market Surveillance of Products required
- Documented Process with change control needed
The Features
The Offer for Distributors
There is a basic offer with a checklist, the Quality Manual template and Quality Policy template available upon request as well. The QMS will be provided in English and additional languages are available upon request.
The Offer for Importer
There is a basic offer with a checklist, the Quality Manual template and Quality Policy template available upon request as well. The QMS will be provided in English and additional languages are available upon request.
The Offer for Manufacturer
There is a basic offer with a checklist, the Quality Manual template and Quality Policy template available upon request as well. The QMS will be provided in English and additional languages are available upon request.