About us
Willibrord Driessen founded Qserve® in 1998. Qserve Group is an independent medical device regulatory consulting firm with a PRACTICAL APPROACH and with in-house expertise needed to bring medical devices rapidly to the market in Europe, US China, Brazil, Hongkong, Korea, and elsewhere.
The Qserve Group comprises:
- Qserve Consultancy B.V. (Medical Device Compliance support)
- Qserve Group US Inc. (Medical Device Compliance support) (US Agent & Official Correspondent)
- Qserve Support B.V. (Medical Technology support)
- QualRep Services B.V. (European Authorized Representative support)
- Qserve International HK Ltd (Hongkong)
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 compliance for Manufacturers of Medical Devices and Health Care&Medical Technology providers.
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.
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 Services and Practical 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.