On Friday 1st November, SEHTA hosted their 2024 International MedTech Expo & Conference at the Hilton London Tower Bridge Hotel. As...

World Health Organization (WHO) has introduced an online platform called MeDevIS (Medical Devices Information System) - an initiative...

During the design and development process phase of your new medical device, our Quality team can ensure your product meets the highest...

Are you in the process of designing and developing a new medical device? We understand the challenges of bringing innovative medical...

This morning (05 March 2024) the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) presented the first in a series of...

By Jacques du Preez & Mark Wiesner Feb 2024 For many years the rest of the world has been utilising the ISO 13485 Medical Device Quality...

You can’t sell or pilot digital health technologies in the UK NHS and Social Care without DTAC and Clinical Safety compliance! The...

On 31st January 2024, we will be co-hosting a workshop called “Practical Risk Management for Software Devices” alongside UCL and...

By Irfan Hassan, Head of Digital Health, AI and Software and UKHSA NHS COVID-19 App Regulatory Lead Psephos Biomedica is very proud to be...

Importance of Internal Audits and Management Reviews Internal audits and management reviews are integral components of a QMS. They play...

How an ISO 13485 QMS Facilitates EU Medical Device Regulation Implementation The implementation of the EU MDR is a significant challenge...

Autumn - The QMS Update Quality Management Services Psephos has decades of experience obtaining regulatory approvals for medical...

Introduction Quality is the cornerstone of any successful manufacturing operation. To ensure the production of safe and effective medical...

Our new video series will provide an overview of the software as a medical device, AI and machine learning landscape. Our Head of Digital...

Are you about to make a 510(k) submission to the US Food and Drug Administration (FDA)? Then don’t forget that from 1st October 2023 use...

Psephos Biomedica and South East Health Technologies Alliance (SEHTA) are pleased to confirm speakers for our Digital Health and SaMD...

It is a privilege to announce that Psephos Biomedica NHS COVID-19 App Regulatory Team in collaboration with UK Health Security Agency,...

Robin Stephens is looking forward to speaking at the Healthtech Innovation Masterclass on Thursday 19th October, run by The MiNT Academy:...

Irfan Hassan, Head of Digital Health, AI and Software and Anusha Venkatesan, Quality and Regulatory Consultant We are pleased to welcome...