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.

Free LIVE Webinar: Systematic Literature Review: How to Empower Data-Driven Decision Making

Join our President, Laurie Mitchell, and Jennifer Tetzlaff from Evidence Partners on Wednesday, November 13, 2019 at 10AM PST / 1PM EST. In this live webinar, we’re covering some best practices to developing a methodologically-sound SLR and available tools and technologies to achieve this.
Click to register for this free webinar or sign up to receive the recording after the event.