Robin Stephens
MeDevIS platform announced to boost access to medical technologies and devices
World Health Organization (WHO) has introduced an online platform called MeDevIS (Medical Devices Information System) - an initiative...
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Louise Hollywood
Jul 91 min read
Device design and development – QMS support
During the design and development process phase of your new medical device, our Quality team can ensure your product meets the highest...
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Louise Hollywood
Jul 91 min read
Device design and development – regulatory support
Are you in the process of designing and developing a new medical device? We understand the challenges of bringing innovative medical...
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Robin Stephens
Mar 53 min read
UK’s MHRA webinar on the new regulatory framework: 05 March 2024
This morning (05 March 2024) the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) presented the first in a series of...
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Jacques du Preez
Feb 123 min read
FDA Final Rule: Medical Device Quality System Regulation Amendments
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...
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Irfan Hassan
Jan 151 min read
Digital Technology Assessment Criteria (DTAC)
You can’t sell or pilot digital health technologies in the UK NHS and Social Care without DTAC and Clinical Safety compliance! The...
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Psephos
Dec 13, 20231 min read
Practical Risk Management Workshop
On 31st January 2024, we will be co-hosting a workshop called “Practical Risk Management for Software Devices” alongside UCL and...
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Irfan Hassan
Dec 13, 20233 min read
We are Award Winners!
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...
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Louise Hollywood
Oct 31, 20233 min read
The Crucial Role of Quality Management Systems & ISO 13485 for medical device manufacturers – Part 3
Importance of Internal Audits and Management Reviews Internal audits and management reviews are integral components of a QMS. They play...
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Louise Hollywood
Oct 16, 20235 min read
The Crucial Role of Quality Management Systems & ISO 13485 for medical device manufacturers – Part 2
How an ISO 13485 QMS Facilitates EU Medical Device Regulation Implementation The implementation of the EU MDR is a significant challenge...
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psephoswebsite
Oct 5, 20231 min read
Psephos Autumn Newsletter
Autumn - The QMS Update Quality Management Services Psephos has decades of experience obtaining regulatory approvals for medical...
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Louise Hollywood
Oct 5, 20238 min read
The Crucial Role of Quality Management Systems & ISO 13485 for medical device manufacturers - Part 1
Introduction Quality is the cornerstone of any successful manufacturing operation. To ensure the production of safe and effective medical...
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Irfan Hassan
Sep 19, 20231 min read
Software as a Medical Device (SaMD) 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...
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Psephos
Sep 19, 20231 min read
FDA electronic submission reminder
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...
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Psephos
Sep 18, 20232 min read
Regulation of Digital Health & AI (SaMD) Seminar
Psephos Biomedica and South East Health Technologies Alliance (SEHTA) are pleased to confirm speakers for our Digital Health and SaMD...
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Psephos
Sep 12, 20231 min read
TOPRA Awards for Regulatory Excellence 2023
It is a privilege to announce that Psephos Biomedica NHS COVID-19 App Regulatory Team in collaboration with UK Health Security Agency,...
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Psephos
Sep 8, 20231 min read
The MiNT Academy: Masterclass in Neurotechnology
Robin Stephens is looking forward to speaking at the Healthtech Innovation Masterclass on Thursday 19th October, run by The MiNT Academy:...
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Irfan Hassan
Jul 19, 20233 min read
Psephos Summer Newsletter
Irfan Hassan, Head of Digital Health, AI and Software and Anusha Venkatesan, Quality and Regulatory Consultant We are pleased to welcome...
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Jane Medina Haines
Jul 18, 20231 min read
The meaning of the word ‘Psephos’
With many of you heading off on summer holidays, perhaps to the beach, we thought we would give you an insight into where the name...
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