Blog
Practical articles on EU MDR, IEC 62304, ISO 14971 and regulatory compliance — coming soon as a newsletter.
From MDD to MDR: Why Europe Rewrote the Rules for Medical Devices
For decades the MDD formed the foundation for medical devices in Europe. Since May 2021 it is history. What triggered the change — and what does the MDR actually alter?
Read moreWhat Does the MDR Mean for Start-ups?
Certification costs, waiting times, and Rule 11: the MDR fundamentally changes the start-up calculus in medtech. What founders need to know — and which strategies have proven effective.
Read moreRule 11: Why Your Software Is Probably Class IIa – and What That Means
Rule 11 in Annex VIII of the MDR makes Class IIa the default for decision-supporting software – not the exception. What that means regulatorily and how manufacturers should approach classification correctly.
Read moreStay ahead of the regulations
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