← Case studies QMS, V&V & Quality
Design controls that engineers will use, not ignore
ISO 13485-aligned process, verification protocols, and traceability without turning the company into a paper mill.
Challenge
Startups either under-document (and fail audits) or over-document (and stop shipping). Both kill medical device companies.
Approach
- Right-size QMS: design controls, CAPA, change control, supplier controls matched to stage.
- Requirements → risk → tests: bidirectional traceability that tools can maintain.
- Verification for hardware and software; validation against intended use and user needs.
- Cybersecurity and usability engineering woven into the same plan—not parallel side projects.
Outcomes
- Audit-ready artifacts without freezing the roadmap.
- Clear ownership of defects, changes, and release gates.
- A quality system that scales from first article to manufacturing transfer.
What this demonstrates
ISO 13485 · Design controls · V&V · Usability · Cybersecurity