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How does software become a medical device, and how does it obtain MDR certification?

From a Notified Body’s Perspective: What Manufacturers Really Need to Know About Classification, Clinical ...
May 12, 2026
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How thorough ISO 27001 auditing could have prevented a global data leak.

We recently became aware of a data leak where personal information of up to 64 million people was leaked ...
May 11, 2026
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Smarter Medicine or Data Dilemma? AI's Role in Healthcare

Artificial intelligence (AI) is rapidly transforming the way healthcare is delivered. From drafting patient ...
May 08, 2026
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What Commercial Value Does ISO 27001 Certification Bring to Hong Kong Businesses?

In today's rapidly accelerating digital landscape, information security has transcended being merely ...
May 05, 2026
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Updated MDR Harmonised Standards: Commission Implementing Decision (EU) 2026/760

Overview of the UpdateThe European Commission has published Implementing Decision (EU) 2026/760, updating ...
Apr 28, 2026
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EU AI Act: what your organisation needs to know in 2026

Non-compliance with the EU AI Act can be expensive. Very expensive. Depending on the breach, penalties ...
Apr 24, 2026
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