Qserve Consultancy advises and supports your organization during implementation and with maintenance of your quality management systems, through to all activities concerning applications for and preservation of registrations world-wide, and/or the required audits, including:
- Auditing: Internal, supplier and distributor
- Authorized Representative, AR
- Biocompatibility & Safety Evaluation (ISO 10993)
- CE Marking Submissions
- Clinical Support Services
- Distributor search Services
- Due Diligence &GAP Analysis
- Medische Technolgie Services (only in Dutch)
- Quality Management System: ISO 13485, QSR, CMD/CAS
- Risk Management (ISO 14971)
- Strategic Consulting
- US Agent & Official Correspondent Services
- Validation (IQ, OQ an PQ)
- 510(k), IDE, PMA submissions
We provide our services "ONE STOP SHOPPING" to new ventures in the medical devices branch in Europe and or the United States, who have a limited knowledge of the EU or FDA regulations, but we are also a valuable partner for medium and large organizations. Our customers benefit from our excellent connections and communications with the Regulatory Authorities and Notified Bodies in Europe and the US, and from our considerable in-house expertise.
In co-operation with our partner Qserve America, Qserve Consultancy can also offer you the services of an Authorized Representative (AR), US-Agent, and an Official Correspondent.
Should you require further information about these services, please contact us.