Prepare a clearer first draft
Draft software requirements and test specifications for engineers to review.
IEC 62304 · Medical device software
Spend less time assembling software evidence.
Software changes can leave documents and test records behind. Connect requirements, designs, tests and change records so engineers can find gaps and prepare software evidence more easily.
See how the software work connects
Link requirements to the design, tests and change records.
Find what is missing before the review
Bring the relevant software records together and flag what needs attention.
About IEC 62304
IEC 62304 defines lifecycle processes for developing and maintaining medical device software, including software embedded in a device and software that is itself a medical device.
Reference: IEC — IEC 62304.
Agree the standard edition, documents and reviews your project needs. KlugSpice helps prepare the evidence; formal assessment and certification decisions remain with the responsible assessors and authorities.
Useful answers
Software lifecycle evidence that stays connected.
Which software records can KlugSpice help prepare?
KlugSpice can prepare requirement, architecture and verification drafts and link them to sources, change records and execution evidence. The device project defines the applicable lifecycle activities, software scope and review expectations.
Is linked test coverage enough to demonstrate conformity?
No. Coverage helps show which requirements have connected verification, but it does not establish the completeness or adequacy of all required lifecycle activities. Engineers must review the work and evidence against the project’s applicable requirements.