EU MDR & IVDR Compliance Vendors
Compare partners for EU MDR and IVDR compliance: technical documentation, remediation and compliance programs for devices and diagnostics.
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
CDMO / CMO · +5 more types
Products: miniDxR, MICA-200C +1 more
“We guide clients through U.S. (FDA), European (IVDR/MDR), Canadian, Australian, Brazilian, Japanese, South Korean, and other international regulatory requirements.”Source: dcndx.com
Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more
CDMO / CMO · +3 more types
Products: ELLA, Pathfinder
“Evolving regulations introduce hidden risks that can derail submissions or trigger costly remediation. StarFish conducts proactive gap analyses and transition planning, helping…”Source: starfishmedical.com
Also offers: Medical Device Product Design & Engineering, Prototyping & Design for Manufacturing, +2 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Obtain the CE mark under the European MDR and IVDR by assessing your device's classification, proposing a development strategy against the General Safety and Performance…”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
Consulting / Advisory Firm · +2 more types
“…Rook’s team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR and IVDR conformity.”Source: rookqs.com
Also offers: Quality Management System (QMS) Consulting, Medical Device & IVD Regulatory Affairs, +1 more
Service Provider · +2 more types
Products: D.AI.M.I.
“Expert guidance navigating MDR and IVDR requirements, ensuring compliant transitions and sustained market access.”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“Post-Market Requirements Business Transformation (SOP, CAPA, GMP, Risk, MDR/IVDR)”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more
Compare listed vendors
What this covers: Support for EU Medical Device Regulation and In Vitro Diagnostic Regulation compliance programs, technical documentation, and remediation.
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| DCN Dx | CDMO / CMO | Medical Device & IVD Regulatory Affairs, Device Clinical Evaluation, PMCF & PMS Documentation | “We guide clients through U.S. (FDA), European (IVDR/MDR), Canadian, Australian, Brazilian, Japanese, South Korean, and other international regulatory…”dcndx.com · reviewed Oct 21, 2026 |
| IQVIA | CRO / Research Services Provider | Medical Device & IVD Regulatory Affairs | “Post-Market Requirements Business Transformation (SOP, CAPA, GMP, Risk, MDR/IVDR)”iqvia.com · reviewed Oct 19, 2026 |
| ProductLife Group | Service Provider | Medical Device & IVD Regulatory Affairs, Device Clinical Evaluation, PMCF & PMS Documentation, Regulatory Platform Implementation & Migration | “Expert guidance navigating MDR and IVDR requirements, ensuring compliant transitions and sustained market access.”plglifesciences.com · reviewed Oct 26, 2026 |
| Rook Quality Systems | Consulting / Advisory Firm | Medical Device & IVD Regulatory Affairs | “…Rook’s team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR and IVDR conformity.”rookqs.com · reviewed Oct 20, 2026 |
| StarFish Medical | CDMO / CMO | Medical Device & IVD Regulatory Affairs | “…Our regulatory team in Victoria supports FDA, Health Canada, and EU MDR submissions.”starfishmedical.com · reviewed Oct 21, 2026 |
| Veristat | CRO / Research Services Provider | Medical Device & IVD Regulatory Affairs, Device Clinical Evaluation, PMCF & PMS Documentation | “Obtain the CE mark under the European MDR and IVDR by assessing your device's classification, proposing a development strategy against the General Safety and…”veristat.com · reviewed Oct 21, 2026 |
| Voisin Consulting Life Sciences | Consulting / Advisory Firm | Medical Device & IVD Regulatory Affairs, Device Clinical Evaluation, PMCF & PMS Documentation | “…For IVD and CDx developers, this means preparing comprehensive clinical performance data and ensuring compliance with new labeling, documentation, and…”voisinconsulting.com · reviewed Oct 24, 2026 |