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Unlocking Trustworthy AI: What You Need to Know About ISO/IEC 42001 Certification
As artificial intelligence (AI) becomes more embedded in the core of business operations, ensuring i
Apr 15, 2025
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AI in Medical Devices: Meeting EU Compliance with AI Act and MDR
The rapid adoption of artificial intelligence (AI) across multiple industries has led to the introdu
Apr 02, 2025
# CE marking
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UK PMS Regulations for Medical Devices: Part 2 – Vigilance & Reporting Requirements
In PART I – Overview & Key Requirements of the UK PMS System for Medical Devices, we explored the
Mar 20, 2025
# CE marking
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UK PMS Regulations for Medical Devices: Part 3 – UK PMS Regulations vs. EU MDR
Key Differences and Impact on CE-Marked Devices in Great BritainIn PART I – Overview and Key Requi
Mar 20, 2025
# CE marking
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UK PMS Regulations for Medical Devices: Part 1 – Overview & Key Requirements
The new UK Post-Market Surveillance (PMS) regulations, introduced through the Medical Devices (Post-
Mar 19, 2025
# CE marking
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Understanding ISO 13485: Excluded Clauses vs. Not Applicable Clauses
ISO 13485 is an international standard that sets the requirements for a quality management system (Q
Mar 18, 2025
# ISO 13485
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