In Vitro Diagnostics Regulatory Writing

Criterion Edge can support your IVDR readiness

Are you prepared to provide an unbiased, comprehensive assessment of the clinical performance of your in vitro diagnostic medical device?

Do you know what technical documents are required?

Criterion Edge is here to help. Our writers and support team can complete a gap analysis to assess IVDR readiness, and provide a clear plan and templates to build technical documents that are IVDR-ready.

The Criterion Edge team includes regulatory writers with IVDR experience and extensive experience with MDR, and first-hand experience as laboratory bench scientists. We understand the research environment, but we also know the importance of a clear, organized writing process to develop the detailed technical documents required by the Notified Body.

Ready to discuss your project and IVDs? Find out how Criterion Edge can support your IVDR preparations today.

Contact us for a free consult on your IVD projects.

Key Deliverables Include:

IVDR Gap Analysis
  • Device specifications
  • Product validation reports
  • Overview of device history and generations
  • Systematic literature review
  • Well-documented literature screening
  • Competitor analyses
  • Risk-benefit analyses
  • General safety and performance analyses
  • Performance Evaluation Report (PER)
  • Scientific Validity Report (SVR)
  • Analytical Performance Report (APR)
  • Clinical Performance Report (CPR)
  • Post-Market Performance Follow-Up Plan (PMPF)

    [WEBINAR] How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions

    In this second installment of a 2-part webinar series on Wednesday May 12, 2021 at 11AM PST / 2PM EST, we will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, and help you identify possible gaps for mitigation prior to submission to regulatory authorities.

    Attendees are eligible for a free consultation and scan of their CER. Spots are limited – click to register for this free webinar.