Standards
ISO 13485
ISO 13485 — International standard for quality management systems in organisations that design, manufacture, distribute or service medical devices.
ISO 13485:2016 covers document control, traceability, supplier control, complaint handling, corrective action and risk-based processes across the device life cycle. Certification is issued by an accredited third-party body.
For buyers, an ISO 13485 certificate from the manufacturer is a baseline check: confirm the certificate scope covers the product being supplied and that it is in date.
Related termsEU MDR 2017/745Certificate of conformityDRAP
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