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