Choosing a medical device Contract Research Organisation (CRO) is not the same as choosing a traditional CRO. Device trials face different evidence standards, including ISO 14155:2020 for clinical investigations, and EU MDR/IVDR expectations for clinical evidence and performance evaluation. Sponsors also need partners with practical experience across UK, EU, and US sites, plus the right mix of monitoring, data, imaging, and post-market follow-up. This guide lists established CROs that work on medical devices and IVDs, verified across multiple reputable sources and ordered by founding year for transparency. Where relevant, we note material M&A since 2020 that affects capability footprints.
We started with third-party “top CRO” lists focused on devices, then validated each company through primary sources such as the company’s website, press releases, and reputable databases. To qualify, a CRO had to: serve medical device and/or IVD sponsors; show UK, EU, or US operational reach; and be corroborated by at least two sources. We excluded pure notified bodies and general consultancies unless they operate a defined CRO unit. M&A and naming since 2020 were double-checked against company news and recognised deal trackers. Founding year, headquarters, and device focus were verified where possible from primary or reputable secondary sources.
NAMSA is device-native and supports sponsors from preclinical through clinical and post-market. Founded in 1967, the company traces its origins to Science Associates and is headquartered in Northwood, Ohio. NAMSA emphasises global device focus and ISO 14155-aligned services, with UK/EU/US reach through operations and partners.
Parexel is a large global CRO that runs device trials as part of its portfolio. Founded in 1982 and headquartered in the Raleigh area, it maintains broad functional services relevant to devices, including data and medical writing, with a sizeable UK/EU footprint. Recent facility moves placed corporate headquarters in Raleigh.
Avania is a medtech specialist with end-to-end services from strategy to post-approval, active in the EU, UK, and US. Its heritage dates to 1988; headquarters are reported in the Netherlands. Avania highlights IVD and combination-product capability alongside conventional device trials.
Premier Research supports device programmes alongside biotech and speciality pharma. Founded in 1989 and based in Morrisville, it operates across the US and Europe with experience in complex and niche indications that overlap device needs.
ICON conducts device as well as drug studies and has grown via acquisitions, including PRA Health Sciences in 2021. Founded in 1990 and headquartered in Dublin, ICON offers global site coverage across UK, EU, and US, with device-relevant methodological expertise.
Medpace is a full-service CRO with device and diagnostics experience, and in-house labs and imaging support. Founded in 1992 and headquartered in Cincinnati, Medpace runs global studies including the UK and EU.
Quanticate is a global biometrics-focused CRO with device and IVD experience under ISO 14155/IVDR programmes. Founded in 1994 and headquartered in Hitchin, UK, Quanticate provides biostatistics, statistical programming, clinical data management, and medical writing across UK/EU/US studies, with US offices in Raleigh, North Carolina.
ClinChoice is a mid-size global CRO with device capability; in March 2023 it acquired CROMSOURCE, an ISO-certified CRO with strong EU presence. The ClinChoice brand’s heritage is reported from the mid-1990s, while CROMSOURCE was founded in 1997 in Verona, Italy. The deal widened EU/US delivery for device studies.
MCRA, now an IQVIA business, combines CRO services with regulatory and reimbursement advisory for medtech and diagnostics. Founded in 2004 and headquartered in Washington, DC, it operates across the US and Europe for device trials.
Veranex is an “Innovation CRO” formed through a 2021 roll-up including Ximedica, Quartesian, Boston Healthcare Associates, Experien Group, IMM Recherche, and design firm Worrell. It offers integrated design, preclinical, clinical, regulatory, and market access spanning devices and IVDs across the US and Europe.
If you are running an EU pre-CE or PMCF programme, confirm the CRO’s ISO 14155:2020 operating procedures and prior MDR/IVDR submissions or NB interactions. For US pivotal studies, check FDA experience by device classification and any need for imaging, core lab, or human factors partners. Digital health and SaMD programmes benefit from CROs with cybersecurity, post-market surveillance, and registry analytics built in.
Selecting a medical device CRO comes down to fit: proven ISO 14155 execution, MDR/IVDR familiarity, therapeutic and modality experience, and a footprint that matches your recruitment plan across the UK, EU, and US.
If you need a biometrics-led partner to de-risk timelines and deliver regulator-ready outputs for device and IVD programmes, Quanticate provides biostatistics, data management, statistical programming, safety, and medical writing expertise aligned to ISO 14155 and EU requirements, from first-in-human through PMCF and registries. Submit an RFI today.
What does ISO 14155 mean for my device study?
It is the GCP standard specific to medical devices, covering design, conduct, recording, and reporting of clinical investigations; sponsors should ensure CRO SOPs align with the 2020 edition.
How do MDR and IVDR change evidence expectations?
Both regulations elevate evidence quality and documentation. For IVDs, MDCG 2022-2 outlines performance evaluation expectations across the device lifecycle.
Why include large, pharma-centric CROs?
Some large CROs operate specialised device teams and global infrastructure. However, device-native CROs may bring faster startup for niche indications, PMCF, or EU market access.