Quality Management

Important requirements are especially the maintenance and further development of the Quality Management System according to DIN EN ISO 13485 and further specifications of Directive 93/42/EEC concerning medical devices. Other quality items are the implementation of internal and external audits as well as the initiation, coordination and monitoring of the necessary corrective actions.

Quality control

  • Constant control of all incoming and outgoing goods
  • Trained specialists
  • Complete documentation

Certifications

  • Construction, manufacuring and sales are certified according to DIN EN ISO 13485
  • This quality assurance system conforms to the requirements of Annex II to Directive 93/42 / EEC concerning medical devices.
  • Compliance of further regulatory requirements of various countries (e.g. FDA)

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