The international requirements for quality management in CE marking are defined by the ISO standard EN ISO 13485 and include the prerequisites for standard-compliant development, production, implementation and maintenance of medical devices within an adequate quality management system.

We support you in the extensive challenges of development, production, installation and maintenance of your customized quality management system according to the international standard EN ISO 13485. The synopsis of the various international requirements and their integration into your company’s internal QM system are just as much a part of our specialties as the development of an expedient documentation system.