MEET THE TEAM
MedQ Consultants B.V. team consists of a core team at their office with the expertise to support a full range of services. In addition, MedQ Consultants B.V. has a network of associates with additional specific knowhow throughout Europe, US, China and Australia all dedicated to guarantee expertise for our regulatory, quality & clinical services and optimal client communication.
René has worked on quality management systems as well as regulatory submissions of medical devices as outlined in the European, FDA, Health Canada, ANVISA (Brazil), TGA (Australia) and IMDRF guidelines and Medical Device Directives.
Is a certified quality management system lead auditor, senior member of the American Society for Quality (ASQ), member of the Regulatory Affairs Professionals Society (RAPS) and member of the Dutch Chapter of RAPS.
Through hands on experience with translating regulatory authority requirements into company’s needs, Robin understands the requirement to design a cost effective and optimal strategy for the device from the preclinical phase into CE-marking and post market surveillance.
Finding order in the chaos is his goal.
Full Service Medical Device CRO
MedQ consultants B.V. is a full service international Contract Research Organization (CRO) for the medical device industry.
We support medical device companies in a highly dynamic environment to cope with EU and global Regulations for all types of medical devices and classifications. The broad range of our services gives you the opportunity to tailor made your choice for support in line with your project and still have access to the full range of knowhow for assessing the impact of the project strategy on compliance with the regulations to avoid market access delay.
For those companies that do not have a presence in the EU, MedQ B.V. also can be your European Authorized Representative.
All services are aimed at providing an economical and practical approach in supporting your business throughout the entire duration of your project and life-cycle of your device. These services include:
- Regulatory compliance
- Technical Documentation for Market Approval
- Quality Management Systems
- Clinical trial strategy and support
- Authorized Representative
Our MedQ Consultants B.V team is specialized, experienced and highly competent in the processes for complying with the medical device directives and regulations.