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.

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)