top of page

50% LESS EXPERT TIME PER MEDICAL DEVICE FILE​

MDR / IVDR: a global Testing & Certification leader cut senior expert time in half on IEC 60601-1-6 and IEC 62304 conformity assessment. Every finding traced back to its source page and paragraph.​

LIVE IN PRODUCTION​

The challenge

One MDR file: 500 to 1,000+ pages across a dozen disconnected documents.​

Clause-by-clause evidence​

Following associated TRFs.

~10h of senior expert time per dossier

Incl. risk of errors navigating manually hundreds of pages.

2 to 3 rounds of rework

Incomplete submissions add days to every turnaround.

How Qleer changes the workflow

BEFORE​

The expert works from the standard's TRF, digs through the client's technical documentation by hand, and fills the TRF.​

WITH QLEER​

Turn IEC 60601-1-6 and 62304 into a structured Digital Truth library.

Map every clause to submitted evidence, across 100% of pages.

Draft TRF in about 15 minutes.​

THE EXPERT​

Works from the full file and a drafted TRF, arbitrates the real gaps, and signs the verdict.​

AI prepares. The expert decides.

Evidence drafted by Qleer, verdict signed by the human expert.​

Measured results

50%​

Less senior expert time per dossier​

10 h to 5 h in a live medical device use case​

80%​

Documentary checks automated​

100% of pages reviewed, not sampling

×2​

Annual capacity, same headcount​

200 to 400 technical files per year​

Impact & Proof

Business impact

Why it holds

+200 dossiers a year and €100k of expert time released - at constant headcount.​

Evidence-linked - every verdict traceable to page & paragraph for 10 years​

Capacity: +200 technical files a year, same headcount​

Human-in-the-loop - the expert arbitrates real gaps and makes final decisions​

Turnaround: Fewer incomplete-file loops to certificate​

Margin: €100k released, unlocking 6 digits additionnal potential gross profit​

Standard-native - IEC 60601-1-6 and IEC 62304 TRFs structured clause by clause​

Quality: Full file coverage replaces expert sampling​

Audit-ready - 100% of pages reviewed, no sampling blind spots​

bottom of page