Quality Assurance & Regulatory Affairs Consulting
Our portfolio of consultancy services covers the complete range a company in the medical devices field requires.
Quality Systems
We assist you to implement requirements set to your quality system, resulting from standards laws and regulations like Title 21 CFR Part 820 (cGMP-Requirements), ISO 9001, ISO 13485, CMDCAS, European Medical Device Directive, etc.
Accreditation of Medical Devices
In cooperation with the customer and the local authorities, we generate applicable applications for accreditation of medical devices.
FDA: 510(k), PMA;
Europe: Technical Files for CE-Accreditation;
Furher marketts: Canada (MDR), Japan (MHLW), Australia (TGA), China (SFDA).