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Industry Feb 18, 2026 · 8 min read
ISO 13485 for medical device startups: when to start, what to skip
Most medical device startups either start their QMS too late (and pay for it during 510(k)) or build a 200-SOP monster too early. There’s a middle path.
I’ve seen this pattern too many times: a medical device startup gets their first FDA pre-submission feedback and panics into hiring a $300K consultant.
When to start
Start your QMS the moment you commit to your first design input requirement. Not before, not after.
The minimum viable QMS
- Document control SOP
- Design control SOP
- Risk management procedure (ISO 14971)
- CAPA procedure
- Training records
- Supplier evaluation procedure
AR
Written by
Alex Rivera
Product Lead
