Services

Qserve Consultancy advises and supports your organization during implementation and with maintenance of your quality management systems, thru to all activities concerning applications for and preservation of registrations world-wide, and/or the required audits, including:

• Due Diligence & GAP Analysis
• Strategic Planning
• CE Marking
• Risk Management (ISO 14971)
• ISO 13485, QSR, CMD/CAS
• Audits
• Biocompatibility & Safety
• Training
• Validation
• (Pre)clinical
• Distributor search
• Authorized Representative, AR
• 510(k), IDE, PMA submissions
• US Agent & Official Correspondent Services

We provide our services to new ventures in the medical devices branch in Europe 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 rapport 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 and our other alliances, 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.