Psephos Biomedica
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"Regulatory and clinical consultants specialising in medical device compliance"
Brighton
•11 - 50 Employees
•Consulting
About Psephos Biomedica
Psephos Biomedica is a medical device regulatory and clinical consultancy that helps companies bring medical technologies to market. Founded in 2001, they provide bespoke support to access UK, EU, Swiss and US markets, working with device classes from Class I to Class III across cardiovascular, neurovascular, surgical and Digital Health/AI sectors. Medical device companies face complex regulatory pathways. Psephos provides experienced support combining regulatory knowledge with practical implementation. Their team offers gap analysis, clinical strategy, evaluation reports, technical file preparation, device registration and UK Responsible Person representation. ISO 13485:2016 certified, they partner with clients to navigate compliance efficiently.
18
Team Members
2001
Founded
Consulting
Sector
Hybrid
Work Environment
Our Vision
A world where innovative medical technologies reach patients faster through expert regulatory guidance and streamlined compliance pathways.
Our Mission
Psephos Biomedica helps medical device companies worldwide bring technologies to market by providing expert regulatory, clinical and quality consultancy services that navigate complex compliance requirements.