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Medical devices

Evidence a notified body accepted

Every change to validated software needed a traceable reviewer, a documented rationale and a signature.

Approval trail on a pull request — under review, approved, merged, each with who and when
Fig. 05 Approval trail on a pull request — under review, approved, merged, each with who and when
Signed merges
100%
Modules
24
Export
Per release
02.1Challenge

Reviews happened. Proving it was the project.

The reviews were being done properly — the difficulty was producing evidence in a form a notified body would accept, per release, without a manual audit each time.

The existing answer was a spreadsheet assembled by a quality engineer over several days per submission.

02.2Approach

Encode the device modules as reviewer rules.

Each of the twenty-four device modules became a path-based reviewer rule with a required approval count, so the right owners are assigned automatically and the merge stays blocked until the rule is satisfied.

Signed commits were enforced on protected branches, making the signature a property of the history rather than a claim about it.

Approval evidence stopped being a project and became an export.
Engineering lead · name withheld
02.3Results

Every merge carries signed approval.

Measured afterwards
  1. 00100% of merges carry signed approval
  2. 0124 device modules encoded as reviewer rules
  3. 02Approval evidence exported per release
  4. 03Explicit deny used for contractor offboarding

Submission evidence is generated per release from the platform itself, with reviewer, rationale and signature attached to each change.

Would this approach fit your organisation?

Bring your repository count, your VCS mix and your compliance constraints. We will tell you honestly whether a staged migration is the right answer for you — sometimes it is not.

Bring
repository count, VCS mix, seat count
Constraints
regulator, classification, contract
We answer
within 24 hours, by an engineer
Contact
sales@rhodecode.com