The mdeg engineering blog

How we build secure, compliant cloud and connectivity for medical devices, written for engineering and regulatory teams.

Two engineers reviewing a 3D device model on screen

Regulatory01 Sep 20269 min read

Most teams classify their software one class too high

Class C is the safe-looking answer and the expensive one. What actually decides the class is your architecture and the risk controls that sit outside the software.

Dr. Christoph Beck

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The mdeg engineering blog

Most teams classify their software one class too high

More posts

What a network fallback has to prove before it ships

The ISO 27701 evidence auditors ask for first

OTA updates are a change control problem, not a delivery problem

Pseudonymisation that survives an ethics committee

A question behind one of these topics?

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