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MedPass International assists medical device companies in developing successful regulatory, clinical and reimbursement growth strategies for Europe. This is a service that is unique to MedPass International and is particularly appreciated by life science investors and early stage companies.
With our 20 years of experience, we have an unparalleled mix of regulatory, clinical and reimbursement expertise that is leveraged to provide clients with efficient and cost-effective roadmaps to market. Our senior consulting staff is diversely skilled and professionally trained in such areas as biomedical engineering, medicine, pharmacy, materials science, toxicology and biocompatibility, biostatistics, healthcare economics and marketing as applied to EU regulations and healthcare law.
Regulatory/Clinical Due Diligence We assist venture capital investors in both the US and Europe to better evaluate investments in the medical device sector by performing detailed regulatory and clinical due diligence at any stage of product development in any size of company.
Regulatory Strategy Development Using our in-depth knowledge of the EU regulatory environment and our extensive contacts with Notified Bodies and Competent Authorities across Europe, we help companies streamline regulatory strategies to expedite clinical trials approvals and CE marking.
Clinical Development Strategies Most clinical development strategies need to go hand-in-hand with regulatory and reimbursement goals. We help companies to determine which clinical data will be required for CE marking and reimbursement and assist clients in devising the most effective route to their marketing goals and in meetings with the authorities to validate the selected approach.
Reimbursement Feasibility and Strategic Analyses With limited resources, companies must identify markets with a favorable reimbursement environment for their devices. We conduct reimbursement feasibility studies in major EU markets such as France, Germany, the UK, Benelux, Italy and Spain to help companies identify potential reimbursement opportunities and to develop reimbursement roadmaps.
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