Navigating MDR: Fresh Insights and Updates
ISO 27001 Requirements: A Clause-by-Clause Reference
ISO 27001 Requirements: A Clause-by-Clause Reference ISO/IEC 27001 has been the reference standard for information security management systems since 2005,
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September 29, 2026
EUDAMED UDI Registration Checklist for Manufacturers
Using the EUDAMED UDI/Devices module became mandatory on 28 May 2026. This follows the Commission Decision (EU) 2025/2371, which formally
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September 28, 2026
Meet the Team: Eva Kurilova-Sahin
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology,
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September 25, 2026
EU AI Act Requirements for AI-Enabled Medical Devices
The regulatory landscape for medical devices is becoming more complex as artificial intelligence becomes part of diagnosis, monitoring, treatment, and
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September 16, 2026
Advancements in AI/ML Standards
Summary Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with
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September 4, 2026
Digital Authorised Representative: A Smarter Approach to Medical Device Compliance
For manufacturers based outside the EU, appointing an Authorised Representative for medical devices is an important part of accessing the
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August 28, 2026
You Can’t Escape CE Marking
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the
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August 21, 2026
SaMD technical documentation checklist for MDR submission
Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under
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August 19, 2026
Role of the Authorised Representative
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the
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