Medical Device and Diagnostic Development and Approval

From concept development through Food and Drug Administration (FDA) and European Union (EU) approval, our team of specialists is highly qualified to assist you in all aspects of medical device and diagnostic regulation throughout the product lifecycle.

FDA Medical Device Development

We provide regulatory strategies and support services to assist you with all aspects of gaining and maintaining FDA approvals for your medical device. Our emphasis on quality, risk management, and science helps you effectively communicate with the agency on their wavelength in support of your product.

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EU Medical Device Development

We support medical device companies from device concept development through CE mark approval. Working with companies that have medical devices and in vitro diagnostic medical devices, we are adept at navigating the complexities and gaining approvals in the EU.

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Medical Device Vigilance Support

The regulatory landscape for medical devices has undergone significant change, but our team can provide a robust solution for your medical device vigilance program by providing the following services:

  • Device Vigilance Project Management
  • Collection and Follow-up of Medical Device Incidents
  • Literature Searches of Medline
  • Electronic Management of Incidents on the ARISg™ Database
  • Expedited Reporting of Medical Device Incidents to Competent Authorities
  • Distribution of Field Safety Corrective Actions and Field Safety Notices

A Global Team of Trusted Experts

Are you in the process of developing an FDA or EMA regulated product? Our experienced team of specialists can help you achieve successful regulatory outcomes in the most expeditious way possible to help you realize the value of those outcomes sooner.

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Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.

We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.

Interested in gaining an industry edge? Let us help you stay up to date.

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