Device Clinical Evaluation, PMCF & PMS Documentation Vendors
Compare partners for medical device clinical evaluation reports, performance evaluation, post-market surveillance and PMCF documentation.
Related workflows
Consulting / Advisory Firm · +2 more types
“…For IVD and CDx developers, this means preparing comprehensive clinical performance data and ensuring compliance with new labeling, documentation, and post-market surveillance…”Source: voisinconsulting.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more
Software / Technology Platform · +2 more types
Products: Castor EDC, Castor CDMS +2 more
“Castor supports registry, survey, and chart review PMCF designs with structured data exports and full audit trails.”Source: castoredc.com
Also offers: Electronic Data Capture (EDC), eConsent, +2 more
Agency · +3 more types
“…Clinical evaluation reports”Source: costellomedical.com
Also offers: HTA Strategy & Submissions, Health Economic Modeling, +3 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“We support the full clinical evaluation process, from the Clinical Evaluation Plan (CEP), which defines the scope and methodology, through the systematic generation, collection…”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
CDMO / CMO · +5 more types
Products: miniDxR, MICA-200C +1 more
“Our team prepares technical documentation, coordinates with notified bodies, drafts clinical evaluation reports, and supports conformity assessment and post-market surveillance…”Source: dcndx.com
Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more
Service Provider · +2 more types
Products: D.AI.M.I.
“Rigorous clinical evaluations and post-market clinical follow-up strategies that demonstrate ongoing safety and performance.”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
Compare listed vendors
What this covers: Regulatory documentation and processes for device clinical evaluation, performance evaluation, post-market surveillance, and post-market clinical follow-up.
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Castor | Software / Technology Platform | — | “A newly CE-marked device starts the post-market clock immediately. PMCF is mandated, but the trigger is easy to miss, so the study is often postponed until a…”castoredc.com · reviewed Oct 25, 2026 |
| Costello Medical | Agency | — | “…Clinical evaluation reports”costellomedical.com · reviewed Oct 21, 2026 |
| DCN Dx | CDMO / CMO | Medical Device & IVD Regulatory Affairs, EU MDR & IVDR Compliance | “Our team prepares technical documentation, coordinates with notified bodies, drafts clinical evaluation reports, and supports conformity assessment and…”dcndx.com · reviewed Oct 21, 2026 |
| ProductLife Group | Service Provider | Medical Device & IVD Regulatory Affairs, EU MDR & IVDR Compliance, Regulatory Platform Implementation & Migration | “Rigorous clinical evaluations and post-market clinical follow-up strategies that demonstrate ongoing safety and performance.”plglifesciences.com · reviewed Oct 26, 2026 |
| Veristat | CRO / Research Services Provider | Medical Device & IVD Regulatory Affairs, EU MDR & IVDR Compliance | “We support the full clinical evaluation process, from the Clinical Evaluation Plan (CEP), which defines the scope and methodology, through the systematic…”veristat.com · reviewed Oct 21, 2026 |
| Voisin Consulting Life Sciences | Consulting / Advisory Firm | Medical Device & IVD Regulatory Affairs, EU MDR & IVDR Compliance | “…From regulatory strategy to medical device clinical investigation management and post-market surveillance & vigilance activity, we provide tailored…”voisinconsulting.com · reviewed Oct 24, 2026 |