DIN EN ISO 13485


Medical Technology

Basic information about DIN EN ISO 13485

The quality offensive of the medical device industry demands DIN EN ISO 13485 certification from all manufacturers and suppliers.

DIN EN ISO 13485 focuses on process-oriented, forward-looking project planning and order processing. Advantages of the standard are an efficient and secure process to ensure customer satisfaction in projects.

The focus of the requirement enhancements is on:

  • project management
  • Development processes (with or without product development)
  • customer norms
  • retention periods
  • product risks
  • Development phase releases
  • Configuration and change management
  • traceability
  • supplier approval

For this purpose, medical product-specific extensions to requirements are described on the basis of DIN ISO 9001:2008. ISO 13485 is based on DIN ISO 9001:2008.

Advantages are to be seen in the internal handling and in the fast market access for companies with a certification in ISO 13485.

Advantages are to be seen in the internal handling and in the fast market access for companies with a certification in ISO 13485. Since 1994, VISTRA has supported companies in all industries in the areas of quality management, environmental management, occupational safety and risk management. With more than 50 annually successful projects in 13485, TS 16949, IRIS, 9001 and 9100 we have secured and improved the market position of our customers.

The optional use of databases, among other things for Intranet management systems (manuals) or law and contract conformity, is one of many effective tools.


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