Medical Device Regulatory Writing

Criterion Edge specializes in the development and writing of Clinical Evaluation Reports for Class I, II and III Medical Devices

Our experienced regulatory writers partner with your internal cross-functional experts to produce a CER that:

  • Presents an in-depth clinical data analysis taken from clinical investigations and literature search results
  • Summarizes the State of the Art background and maturity of current technology for your device
  • Establishes a strong Equivalence argument (if needed)
  • Provides clear summaries of Post Market Surveillance data and Risk-Benefit analysis

Medical Information Specialists will design a comprehensive literature search protocol, with complete documentation of the literature screening and data extraction process. QC reviewers ensure the document is scientifically sound, accurate and adheres to current guidelines and your internal structure. Ask about our fully-developed CER template or we can follow your internal report template.

Read more about our compliance with current MedDev guidelines and MDR regulations affecting CERs. Contact us for more information on how we can help your team.

RAPS Regulatory Convergence 2019

September 21-24, 2019

Philadelphia, PA

Register today to examine regulatory challenges and solutions with top industry professionals.

Book a consultation with us! President Laurie Mitchell and CEO Lalitha Jonnavithula will be taking meetings at booth #349. 

Stop by for exclusive assets, tips, or to discuss regulatory or medical writing projects. And while you’re there… sign up for the chance to win a FREE Amazon Echo!