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Topra 2023 Regulatory Awards innovation winner

Software as a Medical Device Video Series 

Our new video series will provide an overview of the software as a medical device, AI and machine learning landscape. Our Head of Digital Health, AI and Software, Irfan Hassan, is going to lead us through this series. 


Video 1: Regulations for the US (FDA), the EU (CE) and the UK (UKCA)

Video 2: Clinical Safety Standards in the UK

Video 3: Web Content Accessibility Guidelines (WCAG 2.1)

Video 4: Information Governance and Data Privacy

Video 5: Cyber Security

Video 6: Generative AI

Psephos provided the regulatory department and lead for the NHS COVID-19 App and works with UKHSA and NHS Digital, as well as numerous startups and companies.

Digital Health, AI, and Machine Learning are transforming healthcare by automating processes, providing new insights, and personalising and speeding up delivery. 


Psephos has a wealth of experience working with mobile health apps, wearables and sensors, telehealth, AI, machine learning, software, apps and digital health platforms to guide you through this fast paced and rapidly evolving sector. Your software is unique and your regulatory and clinical solution will be specific to you.


Psephos services include:

- Regulatory and Clinical Strategy for Software and AI devices

- Categorising software based on ISO 62304

- Software Development, Verification and Validation

- Regulatory Device Classification

- UKCA Marking, CE Marking and FDA guidance

- Technical File Preparation, Gap Analysis and Updates

- Notified and Approved Body Selection

- Executive Level Coaching



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