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Louise Hollywood
- Oct 31
- 3 min
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...
10 views
Louise Hollywood
- Oct 16
- 5 min
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...
15 views
psephoswebsite
- Oct 5
- 1 min
Psephos Autumn Newsletter
Autumn - The QMS Update Quality Management Services Psephos has decades of experience obtaining regulatory approvals for medical...
8 views
Louise Hollywood
- Oct 5
- 8 min
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...
30 views
Irfan Hassan
- Sep 19
- 1 min
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...
11 views
Psephos
- Sep 19
- 1 min
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
- 2 min
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
- 1 min
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
- 1 min
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
- 3 min
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
- 1 min
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...
9 views
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