Medical device companies need to think about clinical data strategy from conception to market, from preparing due-diligence ready datasets for funders to post-marketing safety surveillance for regulatory authorities. BBCR can help.

Medical devices have their own special complications as it relates to clinical trials. We work closely with each client to bring device innovation to market faster and more affordably.

Working with the BBCR team will help that streamlines clinical trials and help you get through the process faster and more efficiently.

March 2021, the FDA published the’ Medical Device Innovation Initiative white paper.” The CDRH recognizes that innovative devices present new scientific and regulatory challenges and proposes actions to facilitate innovative medical devices’ development and regulatory evaluation. These actions include the innovation pathway: Priority Review Program for Pioneering Technologies.

BBCR consulting offers the knowledge and experience to get an advantage and navigate the FDA innovative pathway. Call us at (617) 401-2327 for a free estimate.

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Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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