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Our in-depth knowledge of European medical device regulations ensures that we can assist you in determining an efficient regulatory strategy for your device. Complying with the new Regulation (EU) 2017/745 (MDR) requirements may seem like a daunting task, particularly with a looming deadline, but Nerac can help you create the right documentation.

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Nerac Analysts have authored 100’s of Clinical Literature Evaluations and Clinical Evaluation Reports for Class I – III devices for start-ups to global medical device manufacturers.

Would you like to learn more about:

  • Medical device Clinical Safety and Performance and State of the Art literature reviews?
  • Clinical Evaluation Plans and Reports (CEP and CER)?
  • Periodic Safety Update Reports (PSUR)?
  • Post-Market Surveillance Plans and Reports (PMS)?
  • Post-Market Clinical Follow-Up Plans and Reports (PMCF)?
  • EU MDR Template or Draft Gap Analysis and/or Remediation?

Your trusted source for breaking news and expert analysis

Your trusted source for breaking news and expert analysis

Your trusted source for breaking news and expert analysis

Meet Our Medical Device Analysts!

Erica Kramer, Ph.D.

Priscilla S. Monarca, M.P.H.

Miriam Sharif-Murray, M.S.

We’re Here When You Need Help

Nerac does more than provide data to our clients. We become a valuable part of your team, offering insights for better, faster business decisions.

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