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.
New EU rules on medical devices to enhance patient safety and modernise public health The Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better...read more
Décret n° 2017-395 du 24 mars 2017 relatif aux pays européens de comparaison pour la fixation du prix des produits de santé remboursables par l’assurance maladie. Article 1 La section 4 du chapitre II du titre VI du livre Ier du code de la sécurité sociale...read more
Medtec Insight – Pharma Intelligence I Informa By Sarah Sorrel More EU Clinical Data Requirements Coming With New Regulations IN THE EU, A TWO-STEP STRENGTHENING of requirements for clinical data means manufacturers and notified bodies need to act now, well...read more