MedTech QMS
ISO 13485:2016 Medical Device QMS Checklist
A medical-device QMS checklist for design controls, production, CAPA, and ISO 13485 audit readiness.
- Estimated time
- 6–12 Months
- Audience
- Quality and Regulatory Teams in Medical Devices
- Last updated
Operational reference for medical-device QMS implementation. Regulatory clearance (FDA, MDR) is separate from ISO 13485 certification.
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Phase 1: QMS & Regulatory
Phase 2: Design & Development
Phase 3: Production & Post-Market
Phase 4: Audit Readiness
FAQ
Does ISO 13485 equal FDA approval?+–
No. It is a QMS standard. Market authorization follows FDA, MDR, or other regulators.
Is ISO 14971 required?+–
Risk management is expected; ISO 14971 is the usual state of the art for device risk.
Can software-only devices use 13485?+–
Yes, with software lifecycle and cybersecurity controls as applicable.
Who audits?+–
A certification body and, for CE, typically a notified body path depending on class.
Related field notes
Quality Management
ISO 9001:2015 for product organizations: process, risk, and audit sampling
Healthcare Privacy
HIPAA Security Rule for HealthTech: ePHI, BAAs, and OCR-ready evidence
Information Security
ISO 27001:2022 audit readiness: what Stage 1 and Stage 2 actually test
The checklists and field notes provided on this website are for educational and informational purposes only. They do not constitute legal, financial, or professional advice. Completing a checklist does not guarantee compliance, certification, or immunity from audits. Always consult with a certified auditor or legal counsel for your specific organizational needs. Full disclaimer