Medical-device software · IEC 62304
For medical-device software teams, Microfilm keeps the verification thread intact in the design record: it captures V&V testing as it happens and signs each record, traced to the requirement and software item it verifies — so the trace is maintained as the software changes, not reconstructed for a design review. IEC 62304 is the lifecycle standard that sets that bar.
Software V&V for a medical device has to stay traceable through the design history file as the software changes — each requirement verified, each verification still standing. Microfilm captures V&V testing as it happens, signs each record, and traces it to the requirement and software item it covers, so the thread is maintained as part of the design record rather than scrambled together before a review. IEC 62304 is the lifecycle standard that requires that maintained thread.
Availability · Capture and signing are free forever on the desktop app. The self-building traceability matrix and audit-package export are Team-and-up cloud features.
What Microfilm is · Microfilm is a desktop app and cloud service that records software QA testing as it happens and turns it into signed, tamper-evident, audit-ready evidence — readable by both human auditors and AI coding agents.
The pain
IEC 62304 expects a clear thread from software requirements through verification, maintained across the lifecycle. When verification evidence lives in scattered screenshots and a matrix re-keyed by hand before a design review, the trace is fragile: it’s slow to assemble, easy to break, and hard to prove to an auditor that it was maintained as the software changed — not stitched together the week before.
How it maps
Run verification the way you already do; Microfilm makes each step part of the design record — traced to the requirement and software item, signed, and maintained as the software changes.
A verification test is captured against the software requirement and the software item it covers — screen, narration, and result — at the moment it runs.
Evidence is signed at execution and written to an append-only log, attributed to the person who ran it — the integrity a medical-device design record is expected to hold.
A failed verification routes to the tracker with the requirement, what was observed, and the capture link — and the regression history shows when it last passed and who ran it.
Requirement → software item → verification → signature stays linked live; the matrix and signed evidence export as a structured package for the design history file.
Instead of a matrix re-keyed before a design review, share a scoped, read-only link to the live verification trace — every requirement mapped to the signed evidence and software item that verify it — for the notified body or regulatory reviewer to search and confirm themselves. Each verdict reads in plain language — “Verified — signed by [tester], unaltered since capture” — not a raw signature to decode. Access is scoped to the review and time-bounded, never a login to your whole evidence corpus. (Team plan and up.)
IEC 62304 ↔ Microfilm
IEC 62304 governs the software lifecycle, not a test tool — Microfilm doesn’t replace your processes. What it does is emit the verification evidence the testing and traceability clauses depend on, captured as the work happens.
Each requirement verified, with results recorded and traceable.
A signed verification record per requirement, linked to the software item and the test case that covers it.
Documented, repeatable test results retained as evidence.
Captured, signed test sessions kept as append-only evidence — replayable, not re-keyed.
A maintained thread from software requirements through verification, kept current as software changes.
Live requirement → software item → verification → signature links, with regression history per test.
Controlled records and problem reports carrying the evidence behind them.
An append-only history; failures handed to the tracker with the requirement, observation, and capture link attached.
FAQ
No. Microfilm produces the verification records a 62304 process relies on — traceable, signed, and attributable. Your software safety classification, lifecycle processes, design controls, and conformity assessment remain your responsibility.
Verification tests link to the software requirement and item they cover, and the links stay live as software changes. The record shows when each verification last passed and who ran it, so you can demonstrate the trace was maintained, not rebuilt for a review.
Yes. Each record is signed at execution and written to an append-only log, attributed to the person who ran the verification — the integrity expected of a design record.
Capture and signing are free on the desktop app. The self-building traceability matrix and audit-package export are cloud capabilities on the Team plan and up.
Microfilm produces the verification records an IEC 62304 process needs; it is not a certification and does not establish your software safety classification, lifecycle processes, or design controls for you. Those processes and any conformity assessment remain your responsibility.
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