Quality control (QC) for medical devices is not optional — it's mandated by ISO 13485 and MDR. A QC process includes: incoming inspection, in-process testing, final product testing, and post-market surveillance. Every test must be documented with traceable records.
Key Takeaways
- QC is mandatory for medical devices — not optional.
- 3 stages: incoming, in-process, final product.
- Every test needs documented, traceable records.
- Device History Record (DHR) per unit is required.