Psephos helps medtech companies build and run the right QMS at the right stage — from concept through to commercialisation. We identify the standards and regulations that apply to you (including ISO 13485, EU MDR and FDA QMSR), then design and implement a system that fits where you are now and scales as you grow — covering document control, auditing, corrective action, and team training.
Whatever your device, IVD, or digital solution, Psephos integrates clinical and regulatory thinking from the earliest stages — because the right evidence strategy early means fewer obstacles later. We support everything from feasibility studies and pivotal trials through to post-market surveillance and PMCF, including clinical evaluation plans and reports, literature reviews, ethics and competent authority approvals, FDA Q-Sub activities, and digital-specific requirements such as DTAC and clinical safety standards.
Non-UK manufacturers selling medical devices or IVDs in Great Britain must appoint a UK Responsible Person (UKRP) to register with the MHRA and maintain legal market access. Psephos acts as your UKRP, handling MHRA registration, maintaining your technical documentation and declarations of conformity, liaising with regulators, supporting any PMS requirements, and keeping you informed of complaints or incidents — so you stay compliant without the complexity.
From the NHS COVID-19 App to early-stage startups, Psephos brings hands-on experience across mobile health, wearables, AI, machine learning, telehealth, and digital platforms. We know this space changes constantly — and we help you stay ahead of it, with regulatory and clinical strategy tailored to your specific software, from classification and technical documentation through to UKCA, CE Marking and FDA guidance.
Clients who trust in Psephos
We've worked closely with some of the world's most innovative medical companies across Europe, North and South America, the Middle East, Africa and Asia.
What our clients say...
Medentech Ltd (part of the Kersia Group) have worked with Psephos as a consultancy partner for our medical device projects since 2021 and we have been very happy to have them work with us on CER preparation and updates since 2022. Psephos advice, expertise and knowledge have been extremely valuable to us in this work. I have found them to be professional, efficient and always helpful in all our interactions.
Sinead Whelan, Regulatory Manager
KERSIA
Working with Psephos Biomedica as our UKRP representative in the United Kingdom is smooth and professional. The team responds quickly, supports us with regulatory requirements, and makes the registration of our medical devices on the UK market much easier.
Paweł Sobociński, CEO
SORIMEX
We received our letter of no objection from the MHRA! I have to say it was an absolute walk in the park – a couple of requests for extra documents - that was it. That is testament to the quality of the submission that you helped us put together - Thanks loads!
Stuart Plant, CEO
CERYX MEDICAL
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