Quality · compliance · regulatory
An audit finding is a design decision you made eighteen months ago and forgot to write down. I build the system that remembers — document control, risk files, validation records — so the audit is a formality and the product is genuinely safe.
| Framework | Gap audit | Documentation | Implementation | Audit support |
|---|---|---|---|---|
| ISO 9001:2015Quality management systems | lead | lead | lead | lead |
| ISO 13485:2016Medical devices — QMS | lead | lead | lead | lead |
| 21 CFR 820FDA Quality System Regulation | lead | lead | advise | lead |
| ISO 14971:2019Risk management | lead | lead | lead | lead |
| IEC 60601-1Medical electrical safety | lead | lead | advise | network |
| IEC 62304Medical device software lifecycle | lead | lead | lead | advise |
Numbering, revision history, approval routing. One source of truth, not six folders named final.
Root cause that finds the cause, corrective action that closes, and evidence it stayed closed.
Disposition, rework, scrap and concession — recorded in a way that survives a five-year lookback.
Design history and device records assembled as you go, not reconstructed the week before an audit.
Approved vendor list, incoming inspection, and the audit questions I actually ask on the floor.
Role-based matrices tied to live procedures, so a revision automatically flags who needs retraining.
A real schedule with real findings. Better my finding than a notified body's.
Inputs, metrics and decisions minuted properly — an hour that produces evidence, not a slide deck.
| Stage | What it proves | Output |
|---|---|---|
| IQ | Installed as specified — utilities, calibration, environment | protocol |
| OQ | Operates across the full range, including the edges and the alarms | report |
| PQ | Performs in your process, with your people, over a real run | report |
| Efficacy | Does the claim hold — temperature, cycle, kill, throughput | study |
| EMC | Pre-scan before the lab, so the lab visit is a formality | pre-scan |
I read your procedures against the standard you claim and hand you the findings list before someone else writes it.
From nothing, or from the binder nobody has opened since 2019, to a system that passes a real audit.
Internal audits, CAPA review, supplier visits and the management review nobody wants to chair.