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ISS AG ISO 13485

The company ISS AG was certified according to ISO 13485 in May 2009. Our scope allows us to execute to the following services for you under the implemented quality management system:

  • Development and development services for hardware and embedded software for medical products as well as stand-alone software as medical products.
  • Design and development verification and validation
  • Clinical evaluations
  • Clinical studies and PMCF studies
  • Technical documentation of medical devices

The corresponding certificate can be found here:

ISO 13485 English pdf icon 16px
ISO 13485 German pdf icon 16px

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ISS AG has been accepted as a member of the BVMA e.V. in November 2016. The Federal Association of Contract Research Organisations (BVMA) e.V. was founded in July 1991 to represent CROs (Contract Research Organisations) which are based in Germany or German speaking countries. To make sure that each member satisfies the high quality demands, all members undergo re-auditing every three years. We are very pleased about the admission and are convinced that we will continue to offer our customers an excellent service in the area of clinical studies.

The corresponding certificate can be found here:

ICH-GCP BVMA e.V pdf icon 16px