Free live masterclass · Thursday 19 November 2026, 10:00 to 11:00 SAST
Claimed vs evidenced: the nine ISO 13485 areas, and the three to fix first
Companies rarely fail an audit because the work wasn't done. They fail because they couldn't prove it. In 60 minutes you'll see exactly where that gap sits in your quality system, and which three things to fix first.
You'll leave with
- Where you really stand. The difference between what your quality system claims and what you could put in front of an auditor today, area by area.
- What “evidenced” looks like. For each of the nine areas: the record an auditor asks for, and what a good one looks like on screen.
- Your three fixes, in order. A simple way to pick the three gaps that matter most, so you stop working a 40-item list and start closing what counts.
Who it's for
Owners, quality managers and responsible pharmacists at South African medical device importers, distributors and manufacturers who are working towards ISO 13485 certification for their SAHPRA licence, or keeping one they already have.
The hour
| 10:00 | Why companies fail evidence, not compliance |
| 10:10 | The nine areas: claimed vs evidenced, with worked examples |
| 10:35 | Picking your three fixes, and the order to do them |
| 10:45 | Your questions, live |
Who's running it
Duane Webber, CA(SA). Twenty years in risk, across energy and health. My own company holds a SAHPRA licence to distribute medical devices, so I carry the same licence you do. I built ISO-13485 Compliance OS and the free Gap Heatmap.
ISO-13485 Compliance OS is software, not a regulator, notified body or certification body, and is not affiliated with or endorsed by SAHPRA. Nothing here is legal advice; no regulatory outcome is promised or guaranteed.