MedPass International is the leading Europe Medical Device CRO,Regulatory and Reimbursement Consultancy specialized, in medical device development and market access.
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.
The Ministry of Health, Welfare and Sport has come to a voluntary agreement with the medical device industry, hospitals and other healthcare organizations to implement a Unique Device Identification (UDI) system for medical devices. The use of this unambiguous...read more
This guideline covers diagnosing and managing endometriosis. It aims to raise awareness of the symptoms of endometriosis, and to provide clear advice on what action to take when women with signs and symptoms first present in healthcare settings. It also provides...read more
New Medical Device Regulation (MDR) have been published in the Official Journal of the EU on May 5, 2017 The new regulation on Medical Devices (EU) 2017/745 was published on May 5 and will take effect from May 25, 2017. The transitional period will officially start...read more