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Artificial Intelligence Circuit
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Digital Health & AI

Developing SaMD?

Need UKCA or CE marking?

Need to prepare a technical file?

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

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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 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.

Our 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

Artificial Intelligence Circuit

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 6-part series. 

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