What is ISO 13485?

ISO 13485 is a specific standard for the medical devices industry. ISO 13485 also in conjuction with Directive 93/42/EEC 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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