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

Contact us for a complete free consult on your regulatory submissions.

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 systematic literature review services.

[Ask the Expert] Safety and Performance Objectives and Acceptance Criteria for the PER

Join us for a LIVE Q&A session on January 26, 2022, at 11AM PST / 2PM EST with President Laurie Mitchell and Dr. Sarah Chavez. They will be answering questions regarding best methods and practices of identifying safety and performance measures and acceptance criteria for the performance evaluation report.

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.