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Psephos Limited is a Bramble Hub partner
This allows us to provide their services / products to UK public sector organisations via our thin-prime model of working on frameworks.
Company Details
Full Company name Psephos Limited
Connect with Psephos Limited
Specialisms
Company Introduction

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 device
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
No matter what classification of device, digital solution or IVD that you have, clinical strategy, clinical evidence and clinical evaluation are central to ensuring your product is safe and suitable for human use, for approval and access to global markets.