A Quality Management System (QMS) is mandatory for medical device companies. ISO 13485 is the standard. Building QMS early saves money — retrofitting is 3-5x more expensive. A lean QMS covers: document control, risk management, design controls, supplier management, CAPA (Corrective and Preventive Action), and post-market surveillance.
Key Takeaways
- ISO 13485 QMS is mandatory for medical devices.
- Build QMS from Day 1 — retrofitting costs 3-5x more.
- Start with document control + risk management.
- Hire a QA/RA manager as one of your first 5 hires.