These CROs focus exclusively on device and combination-product trials, offering ISO 14155-compliant study design, monitoring, biostatistics, and regulatory support.
Medical Devices
Anatomise Biostats (UK / Australia)
Biostatistics & Bioinformatics consultancy, MedTech-focused, Boutique.
Offers end-to-end statistical and bioinformatics support for device trials, including protocol consultation and performance evaluation analyses. Complies with global device standards (ISO 14155, FDA 510(k), CE Mark) in its reporting and quality systems.
Archer Research (Belgium)
Full-service CRO, MedTech-focused, Boutique.
Provides clinical operations, data management, and biostatistics for ISO 14155 trials and post-market performance studies. Guides sponsors through EU MDR/IVDR submissions with custom statistical analysis plans.
Avania (Netherlands)
Full-service CRO, MedTech-focused, Mid-Tier.
Designs and executes early- and late-phase device trials, including feasibility, safety, and real-world evidence studies. Provides biostatistics, monitoring, and regulatory dossier preparation.
Beaufort CRO (USA)
Full-service CRO, MedTech-focused, Mid-Tier.
Specializes in usability and human-factors evaluations alongside pivotal device studies. Delivers data analysis and post-market surveillance to inform next-generation design.
Devicia (Netherlands)
Full-service CRO, MedTech-focused, Boutique.
Offers complete trial management for medical device and IVD sponsors under MDR and IVDR frameworks. Handles feasibility, monitoring, and statistical reporting.
DICE CRO (Belgium)
Full-service CRO, MedTech-focused, Mid-Tier.
Provides clinical design, biostatistics, imaging review, and data management for device studies. Supports sponsors through EU and US regulatory pathways with integrated biometrics teams.
Hopkins MedTech Compliance (USA)
Specialized CRO, MedTech-focused, Boutique.
Conducts analytical performance and human-factors testing for IVDs and device software. Produces regulatory-grade study reports for FDA and international markets.
MCRA (USA)
Full-service CRO, MedTech-focused, Mid-Tier.
Delivers study start-up, site management, and biostatistics for device and combination-product trials. Advises on IDE/CE submissions and PMCF planning.
NAMSA (USA)
Full-service CRO, MedTech-focused, Mid-Tier.
Provides global device trial execution, central lab services, and data analytics. Supports FDA 510(k) and CE Mark pathways with strategic regulatory guidance.
Qserve CRO (Netherlands)
Full-service CRO, MedTech-focused, Mid-Tier.
Manages device and IVD clinical investigations from feasibility through pivotal trials. Offers regulatory consulting for MDR, IVDR, and FDA device classifications.
RQM+ (USA)
Full-service CRO, MedTech-focused, Mid-Tier.
Integrates quality, regulatory, and clinical operations for device and SaMD programs. Provides biostatistics, monitoring, and post-market surveillance services.
ISS AG (Switzerland)
Specialist CRO, MedTech-focused, Mid-Tier.
Offers clinical operations plus a dedicated statistics group for sample-size, SAP development, and validated SAS analyses. Serves device sponsors with end-to-end trial design and data reporting.
Novineon CRO (Germany)
Full-service CRO, MedTech-focused, Boutique.
Conducts MDR/IVDR trials, PMCF, and performance evaluation studies with in-house biostatistics and data management. Provides CER/CEP writing and statistical analysis for EU submissions.
ABX-CRO (Germany)
Full-service CRO, MedTech-focused, Mid-Tier.
Runs clinical and pre-clinical programmes for imaging devices and radiopharmaceuticals under ISO 14155. Supplies simulations, SAPs, and statistical evaluations for oncology and diagnostic studies.
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