ISO 13485 - Chapter 7

Original text

Expert opinion

Product Realization

This chapter of the standard deals with the development of the product with all its facettes.

The chapter specifies the following aspects:

  • Planning of product realization
  • Customer-related processes
  • Design and development
  • Purchasing
  • Production and service provision
  • Control of monitoring and measuring equipment

Any questions left? Contact Avanti Europe to discuss with an expert