DIN EN ISO 13485

Medical Devices – Quality Management

On a national and international level, medical device manufacturers have to comply with high demands, especially in respects to safety and reliability of their products and services as well as the minimization of risks of their products. The same applies to companies that develop, produce, maintain, distribute, or use medical devices. Essential contents arise inter alia from the Medical Devices Act (MPG) and Directive 93/42/EEC as well as from Canadian, U.S. or Japanese requirements. Both customers and national authorities expect proof of conformity in this matter.

ISO 13485 is a process-oriented standard, which in addition to the industry-specific also contains almost all requirements of the ISO 9001 standard, with which it is no longer necessarily linked since 2003. It takes into account specific requirements for medical devices. These are mainly referring to product safety, detailed documentation and burden of proof as well as the development of risk management.

With a DQS MED certificate according to ISO 13485 a company provides evidence that they have fulfilled their obligation regarding product risks and application. Further you

  • prove compliance with legal regulations or contractual agreements,
  • minimize and controls risks,
  • emphasize your competencies, rather preventing errors instead of correcting them,
  • improve the quality of corporate performance,
  • increase customer and employee satisfaction,
  • increase the transparency and efficiency of internal processes and
  • save time and costs.

Although no compelling combination between the two standards does exist, in the course of a certification according to ISO 13485 the ISO 9001 can be established with small additional effort.