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Qserve Consultancy BV

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
Training
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.


Bedrijfsnaam: Qserve Consultancy BV
Adres: Asterweg 19 D12 unit 6
NL-1031 HL AMSTERDAM
 
Tel. nummer:+31 (0)20 78 82 630
Fax nummer:+31 (0)20 78 82 631
Website:www.qservegroup.com