Details

Medical devices with rameus solutions

Thanks to nearly 10 years of experience within the medical device industry, rameus solutions is able to support you in all business critical and regulatory relevant aspects of the medical device industry.

The core topics are mostly similar with regards to Management Systems. Typically we support with regards to questions in these areas:

  • Risk Management for Medical Devices (ISO 14971)
  • Software development (ISO 62304)
  • Information Security (ISO 27001)
  • Audit preparation (ISO 13485)
  • Treatment of audit results (ISO 13485)
  • Training in new standards or regulations (MDR, IVDR, GDPR)

As a flexible partner we either fill this role permanently as an external service provider or via Interim Management as a mandate within until you find a permanent solution.