What is ISO 13485?
ISO 13485 is a specific standard for the medical devices industry. ISO 13485 also in conjuction with Medical Device Regulation MDR (EU) 2017/745 specify die requirements for a Qualitymanagement-System (QMS) for a medical devices manufacturer. The focus of the standard is on product’s safety.
Standard is divided in five main parts:
- Qualitymanagement – System
- Management requirements
- Resource requirements
- Product realization
- Measurement, analyse and improvement
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