PHARMExcel is a full service medical device and diagnostics CRO, supporting academics, university spin-outs and medtechs to move innovations from concept to clinical investigation and beyond. We work with device manufacturers, university teams and early-stage companies to design and deliver Class I–III device and diagnostic studies that are regulatory compliant, operationally realistic and aligned with your commercial pathway.
Medical device and diagnostics clinical studies explained
Medical device and diagnostics clinical studies are designed to show that a device is safe, performs as intended and delivers a meaningful benefit for patients and clinicians. Unlike traditional drug trials, device investigations often involve iterative design changes, usability assessments and performance evaluations in real clinical settings. Studies may range from early feasibility work in small cohorts through to larger confirmatory investigations and post-market follow up.
These investigations must comply with device-specific good clinical practice (ISO 14155) and sit within the wider regulatory framework for UKCA and CE marking. For many academic teams and early stage companies, understanding how clinical investigations fit into overall development and market access strategies is a crucial first step.
Why medical device trials need specialist expertise
Medical device trials differ from drug trials in risk classification, study design and regulatory expectations. Device class (I to III), category, intended use and whether the device is invasive, implantable or software-driven all influence the level of scrutiny and the type of clinical evidence required. Combination products, such as device-ATMP or drug-device combinations, add further complexity.
Sponsors must navigate evolving UK and EU frameworks, including the Medical Device Regulation (MDR), and understand the MHRA requirements for clinical investigations. Questions about device classification, the most appropriate conformity assessment route, the role of an ISO 13485 quality management system and how clinical data will support UKCA and CE marking need clear, practical answers.
Experience in device-specific GCP, UK and EU submissions and post-market expectations helps avoid missteps that can delay approvals or require costly redesigns. A medical device CRO that understands these nuances can guide sponsors through classification, protocol development, regulatory engagement and ongoing safety management with confidence.
Our experience in medical device clinical research
PHARMExcel has a proven track record in medical device and diagnostic studies for both academic and commercial sponsors, including ATMP and combination trials. Our teams have delivered clinical investigations across multiple therapeutic areas, with particular experience in hepatology, neurology, ophthalmology, cardiology, infectious diseases, ENT, endocrinology, oncology and surgery/prosthetics.
Our portfolio includes interventional Class III hepatology studies such as the Alfapump system trial in refractory ascites, and the first-in-human, multi-centre DIALIVE liver dialysis device study in alcohol-related cirrhosis with acute on chronic liver failure. In oncology, we have supported device-ATMP combinations, including a UK multi-site, open label intraperitoneal study of INKmune in patients with relapsed or refractory ovarian cancer.
We have also worked on innovative Class I and prototype devices, such as a CE marked nasal prosthetic device for speech in ENT indications and an adaptive prosthetic liner for transtibial amputees. In infectious diseases, our experience includes an IMP-device combination trial evaluating nebulised surfactant delivered via a dedicated device for the treatment of severe COVID-19. This breadth of work gives our teams a practical understanding of how to integrate device investigations into real clinical workflows.
We’re focused on getting your trial through the regulation process
Here are some successful medical device clinical trial highlights
BRAIN MACHINE INTERFACE
Feasibility and early safety clinical trial for Forest 1 device using ultrasound technology targeting the whole brain to improve people’s mood and reduce depression. Learn more.
Sponsor – Barking and Havering NHS Trust
HEPATOLOGY Class III -Interventional
Multi-centre, open, randomised, and controlled trial of Alfapump system conducted in patients diagnosed with refractory ascites.
Sponsor – Sequana Medical
ENT Class I (CE marked)
Prospective, multi-site study utilising a CE marked Cleara Talk nasal device in patients as prosthetic treatment option for nasal speech.
Sponsor – Converse Healthcare
Support for academics, spin-outs and start-ups
PHARMExcel has a long history of working with academic investigators and university spin outs who are bringing first-in-kind or early-generation devices to the clinic. For many of these teams, the key questions at the outset are not only about trial design, but about how clinical investigation supports translational and commercial goals.
To support this, our CEO Yvanne Enever, offers a no-fee consultation for academics, spin outs and medtechs. This initial discussion can help clarify:
- How to determine the correct classification and category of your medical device
- Which UK and EU regulatory frameworks apply
- How recent legislative changes may affect your development pathway
- Why an ISO 13485 quality management system is important
- What the UK MHRA submission and assessment process involves for clinical investigations
- How UKCA and CE marking routes work in practice
- What a conformity assessment is and what evidence is required
- How post-market surveillance obligations may shape ongoing data collection
This conversation gives sponsors a clearer view of their options and helps identify the most appropriate route into clinical evaluation. Where needed, we can also support grant applications by providing input on study design, regulatory strategy and operational feasibility.
Our approach to medical device and diagnostics studies
Our starting point for any medical device study is a clinical investigation plan (protocol) that reflects both regulatory requirements and the realities of clinical practice. Working with sponsors, we define objectives, endpoints, eligibility criteria and follow up schedules that fit the device risk profile, intended use and stage of development.
From there, we provide tailored support that can include protocol development, UK and EU device regulatory approvals, project and study management, site selection and initiation, risk-based monitoring, device safety management and reporting, and statistics and data management. Our quality management system is certified to ISO 9001:2015, and our clinical operations staff are trained in GCP and relevant ISO standards for medical devices.
For sponsors looking beyond the UK, we collaborate with dedicated partners in other countries and can discuss global requirements. Throughout, our focus is on practical, proportionate processes that protect patients and generate reliable data without overburdening sites.
Why sponsors choose PHARMExcel as their medical device CRO
Sponsors and sites value our combination of personal engagement and deep regulatory understanding. Clients have described PHARMExcel as the most effective and collaborative CRO they have worked with, highlighting our grasp of GCP-compliant clinical trials and our commitment to understanding each study in detail.
As a smaller, agile CRO, we offer direct access to our CEO and senior team, bringing more than 30 years of research experience, particularly in the academic sector, to each project. Our knowledge of UK and EU regulatory frameworks helps sponsors align their investigations with medical device regulation requirements and avoid unnecessary delays.
Our service model is flexible and transparent. Detailed, itemised costings and a mix-and-match approach to services allow sponsors to select the support they need while keeping full visibility over budget and deliverables. Above all, we work as an extension of your team, with collaboration and practical problem solving at the core of how we operate.
"PHARMExcel came in to help my team finalise an UK study. Yvanne Enever and her people formed a capable, competent, and efficient partnership in this process and were quick to start and pick up the pace. Provided great support and knowledge about UK clinical trial legislation and IRB process. "
Jeroen Capel | Director Clinical Operations, Sequana Medical
Discuss your next medical device study
Whether you are planning your first clinical investigation for a novel device, preparing to evaluate a combination product or scaling up to a multi-centre study, PHARMExcel can help you determine the right regulatory route and design a study that supports your commercial goals.
To explore how our medical device CRO services could support your next project, contact us to arrange a no-fee consultation with our CEO or speak directly to our clinical operations team.
FAQs
What does a medical device CRO do for sponsors?
A medical device CRO provides specialist support for clinical investigations of devices and diagnostics, from early feasibility work through to post-market studies. This typically includes advice on device classification, protocol development, regulatory and ethics submissions, project management, monitoring, safety reporting, data management and biostatistics, with a clear understanding of ISO 14155 and how evidence will support UKCA and CE marking.
What types of medical devices does PHARMExcel support?
We support clinical investigations across device classes I to III, including implantable systems, external devices, diagnostics and combination products. Our experience spans therapeutic areas such as hepatology, ophthalmology, cardiology, infectious diseases, ENT, endocrinology, oncology and surgery/prosthetics, as well as device-ATMP and drug-device combinations. For each project, we work with sponsors to understand the device, its intended use and the context of care.
How do you support UK and EU regulatory submissions for devices?
Our teams help sponsors navigate UK and EU regulatory frameworks for medical devices and diagnostics. This can include guidance on classification and regulatory strategy, preparation of documentation for MHRA submissions, support with interactions with notified bodies and alignment of clinical investigation plans with MDR and related requirements. We also advise on how clinical investigations fit into wider conformity assessment and post-market surveillance obligations.
How do you work with academic investigators and spin-outs?
We have extensive experience working with academic investigators, university hospitals and spin out companies. Our role often begins with helping teams understand how clinical investigation fits into their translational and commercial objectives. Through our no-fee consultation and ongoing project support, we provide practical guidance on grant submissions, regulatory pathways, study design, governance and operational delivery, allowing researchers to focus on their innovation while we help manage the regulatory and operational requirements.
What study types and development stages can you support for medical devices?
PHARMExcel supports device clinical investigations from early feasibility and first-in-human work through to larger confirmatory studies and post-market surveillance. This includes single centre prototype evaluations, multi-centre interventional studies, combination product trials and post-market clinical follow up. For each stage, we adapt our monitoring, data review and safety management plans to reflect the device risk profile, development phase and regulatory expectations.
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