Software in Medical Devices, a blog by MD101 Consulting

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They've raised the bar!

If you are a regular visitor of this blog, you noticed that almost three months elapsed between the last two articles on cybersecurity.
That's not what I planned.

The time dedicated to this blog was totally swallowed by the other facets of my job. Namely filling the gap between the current level of compliance of manufacturers, and the new expectations of notified bodies and regulatory authorities in the European Union. The bar has been raised!

It gives you a sense of what we're getting into with the new MDR.



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