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Clinical Quality Assurance

As a manufacturer of medical device products, we support you in adapting your clinical quality management to the current standards (DIN EN ISO 13485, ISO 14155) and their requirements.

We can offer you the following services:

  • Creation of SOPs in the field of clinical research
  • Individual adaptation of SOPs to your requirements
  • Updating of SOPs in the event of changes in regulations
  • Implementation of audits (system, supplier, study site audits)
  • Support in the run-up to inspections and audits

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