Psephos is a medical device regulatory, clinical and quality consultancy. We are a highly focused, experienced team that provide regulatory, clinical and quality services to manufacturers and producers of Class I medical devices through to high risk Class III medical devices, covering areas such as Digital Health and AI, Cardiovascular, Neurovascular, Surgical Diagnostic and Invitro Diagnostic Devices (IVDs).
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.
Company details
Full Company name
Psephos
Address:
UK Office: Sussex Innovation Centre Science Park Square Brighton, BN1 9SB
Contact Phone number:
01273 704 527
Website URL:
Social accounts:
Company Linkedin account:
www.linkedin.com/company/psephos-biomedica
More About Bramble Hub
Subscribe To Our Newsletter
Contact Us