MedPass International is the leading Europe Medical Device CRO,Regulatory and Reimbursement Consultancy specialized, in medical device development and market access.
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Latest DeviceMed publication
By Amélie Archer & Lucile Bernard – Regulatory Affairs and Contract Associates, MedPass International
MedPass, a Medical Device CRO, Regulatory and Reimbursement Consultancy, helps companies worldwide bring new technologies to the market by providing a full range of services in medical device development and market access. Key areas of focus include:
- Strategic Consulting
- Clinical Evaluation
- Clinical Operations
- Regulatory Affairs
- EU Reimbursement
- Authorized Representative services
- Legal Representative services
For over 25 years, MedPass has helped to advance the development of breakthrough medical device technologies by offering a broad range of strategic and operational services tailored to meet the needs of our clients.
With such a wide range of Medical Device CRO, Regulatory and Reimbursement services, MedPass is able to offer truly comprehensive assistance across the entire spectrum of the medical device lifecycle. From early identification of regulatory and reimbursement pathways, through clinical trial design, set-up and execution, CE marking, reimbursement and Post Market Clinical Follow-up (PMCF), MedPass experts help companies streamline the development and market access pathways so that physicians and patients can benefit from new technologies as soon as possible.
The European regulatory landscape for medical devices is changing. A new Medical Device Regulation (the MDR) will be implemented in 2020 which will profoundly change the current CE marking system. In the meantime, the regulatory environment for conducting clinical investigations and gaining market approval for new devices in Europe is being tightened. Moreover, country to country differences continue to exist on the national level, particularly with regard to clinical investigations, funding and reimbursement and post market surveillance.
MedPass is uniquely qualified to meet clients’ needs in the current environment. We bring a multilingual and multicultural, diversely skilled and professional team with strong clinical research, regulatory and reimbursement experience. Our consultancy group includes individuals with Competent Authority, Notified Body and healthcare economics credentials. Specially tailored services can be arranged to meet clients’ specific objectives. Emphasis is placed on communication with the client at every stage of project progress.
Issued in June 2016, raises the bar for pre and post market clinical data requirements. MEDICAL DEVICES DIRECTIVES CLINICAL INVESTIGATION CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC ...read more
18 August 2015 Sarah Sorrel The Council of the EU’s agreed amendments to the requirements for clinical evaluation reports under the new Medical Device Regulation are substantial. And so are its proposed amendments to clinical investigations and post-market clinical...read more
MedPass the EU’s leading Medical Device CRO has taken another significant step in the development of its strategic group with the announcement of a number of high profile appointments. David Francis former Global Head of Active Implantable Devices at BSI, Rebecca...read more