Generate defensible clinical and performance evidence. Our medical writers, clinicians and evidence specialists plan, author and maintain clinical evaluations for medical devices and performance evaluations for IVDs, across the full lifecycle.
CEP, CER, clinical literature review, equivalence analysis, PMCF, clinical evidence gap assessment and periodic updates, scoped to the device's classification, conformity route and existing evidence.
PEP, scientific validity, analytical performance, clinical performance, PER, PMPF and performance evidence updates for Class A to D devices.
How the IVD documents connect →Shared capabilities: literature methodology, state-of-the-art analysis, benefit–risk, Notified Body query responses. Clinical content is reviewed by medically qualified specialists and PhD scientists. Evidence requirements vary by product, classification, conformity route and available data, so every plan starts from your device.
A standalone engagement with a fixed scope and a written report.
Reviewers check the method before the conclusions. Every review we run documents each step so it can be repeated and audited.
Questions, databases, search strings and inclusion criteria, agreed before searching.
Documented searches with dates and hit counts in PubMed, Embase, Cochrane and others.
Two-stage screening with exclusion reasons, and appraisal of each source's suitability and contribution.
Evidence tables, then analysis against safety, performance and benefit claims.
Every conclusion traced to its source, with a PRISMA-style flow and full references.
A clinical evaluation report that follows a structure reviewers recognise, with a plan that states how each conclusion will be reached before data is gathered.
Typical CER structure · based on MEDDEV 2.7/1 rev 4 Appendix A9, adapted for the MDR
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.
