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:
Due Diligence & GAP Analysis
Strategic planning
EU: CE Marking submissions
USA : FDA: IDE, PMA and 510(k) submissions
Canadian (MDR) medical device registrations and CMDCAS
Biocompatibility studies, (pre) clinical studies
Quality Management Systems, ISO 13485 and auditing
Validations: product & process, IQ, OQ, PQ, PPQ
Training in regulatory compliance, US Agent & Official Correspondent
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.
Our Philosophy
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.
“We bring you to the market faster!”
