1441 RS Purmerend
1440 AH Purmerend
Phone: +31 299 412000
Fax: +31 299 412001
Willibrord Driessen founded Qserve Consultancy in 1998. Qserve Consultancy is an independent medical device regulatory consulting firm with an in-house expertise needed to bring medical devices rapidly to the market in Europe and elsewhere. Qserve Consultancy is part of the Qserve Group.
The Qserve Group comprises:
Three divisions, two in Europe and one in the United States:
The Netherlands, Amsterdam:
Qserve Consultancy B.V.
Qserve Support B.V.
The United States, New Hampshire, Claremont:
Qserve America Inc. (A member of the Qserve Group).
Qserve, as Medical Device Consultants, facilitates product market approval of your device, e.g., CE Marking in Europe and FDA approval in the USA, and provides Quality Management System implementation of ISO 13485, auditing conform ISO 13485, as well as (pre)clinical evaluations. We can also be of help with post marketing compliance issues, such as vigilance. Qserve is the expert in quality assurance and regulatory affairs for manufacturers of medical devices.
We have a unique combination of in-house expertise, over a wide range of products, in a variety of regulatory and quality systems for medical devices such as:
Our highly-skilled, technical, regulatory and quality staff in Europe and the US have almost 100 years of experience between them, and includes certified Lead Auditors. Projects are handled with utmost priority and attention to detail. They can be undertaken at our offices or at your own premises. Qserve is proud of the fact that many of our clients return to us for additional advice year on year. Qserve maintains excellent relationships with regulatory authorities, government agencies, testing laboratories and others involved with medical devices.
Through our “ One-Stop-Shopping” program, we are able to offer you a number of turnkey modules which can synchronize your EU and US submissions saving you time and money.
Our challenge is to guide and to manage your company in the most efficient and practical ways to achieve faster product registration and market approval.
The core philosophy behind our service and approach is the optimization of practical advice, customized to an individual company’s culture and needs, in the most efficient and cost-effective manner. Achieving optimal acceptance and recognition of your registration and quality management system, accelerates complete market approval.
10.02 Further education and training
Our Services 09.10.2008
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
* Biocompatibility & Safety
* 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, 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.
10.04 Professional institutions
10.08 Logistic services
10.08.06 Consulting for health organisations
10.10 Technical equipment management, Test houses/Certification Bodies
10.10.02 Certification and testing of medical devices, quality assurance