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Regulatory and clinical consultants specialising in medical device compliance

Psephos Biomedica is a medical device regulatory and clinical consultancy. Founded in 2001, we have worked for over
20 years with clients from around the world to bring medical technologies to market. We provide bespoke regulatory and clinical support and representation to access the UK, EU, Swiss and US markets. 

We are a highly focused, experienced team that works with all classes of devices from Class I to Class III, covering areas such as Digital Health and AI, Cardiovascular, Neurovascular, Surgical and IVDs.

Contact us today to find out how we can support you in bringing your medical technology to market and maintain regulatory compliance.

Work with the Regulatory team that won the

TOPRA 2023 Regulatory Excellence 'Innovation' Award:

Psephos is proudly certified to ISO 13485:2016,
and we are members of the following organisations:

ABHI logo
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over 20 years of Psephos
(Founded in 2001)

CLIENTS

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.

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