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November MedTech Regulatory Update
On Friday 1st November, SEHTA hosted their 2024 International MedTech Expo & Conference at the Hilton London Tower Bridge Hotel. As...
Jane Medina Haines
Nov 14, 20242 min read
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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...

Robin Stephens
Aug 7, 20242 min read
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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...

Louise Hollywood
Jul 9, 20241 min read
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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...

Louise Hollywood
Jul 9, 20241 min read
17 views


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...

Robin Stephens
Mar 5, 20243 min read
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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...

Jacques du Preez
Feb 12, 20243 min read
29 views


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...

Irfan Hassan
Jan 15, 20241 min read
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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...
Psephos
Dec 13, 20231 min read
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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...

Irfan Hassan
Dec 13, 20233 min read
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Jacques du Preez
Nov 21, 20230 min read
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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...

Louise Hollywood
Oct 31, 20233 min read
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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...

Louise Hollywood
Oct 16, 20235 min read
31 views


Psephos Autumn Newsletter
Autumn - The QMS Update Quality Management Services Psephos has decades of experience obtaining regulatory approvals for medical...
psephoswebsite
Oct 5, 20231 min read
16 views


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...

Louise Hollywood
Oct 5, 20238 min read
47 views


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...

Irfan Hassan
Sep 20, 20231 min read
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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...
Psephos
Sep 20, 20231 min read
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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...
Psephos
Sep 19, 20232 min read
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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,...
Psephos
Sep 13, 20231 min read
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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:...
Psephos
Sep 8, 20231 min read
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Psephos Summer Newsletter
Irfan Hassan, Head of Digital Health, AI and Software and Anusha Venkatesan, Quality and Regulatory Consultant We are pleased to welcome...

Irfan Hassan
Jul 20, 20233 min read
15 views
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