be-on-Quality GmbH

be-on-Quality your partner for reliable regulatory results.

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We are experts in medical devices and in-vitro diagnostics, in the areas of quality management, regulatory affairs and clinical affairs.

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Development of sustainable solutions individually adapted to the needs of our customers.
We support manufacturers with all regulatory issues from the initial idea to all approvals and registrations.

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Supporting our customers with regulatory challenges.
Implementing efficient and effective processes to ensure the quality and safety of medical devices

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• Implementation of a quality management system according to ISO 13485 and MDR/IVDR
• Support for conformity assessment according to MDR/IVDR
• International registrations
• Consulting on the establishment of a regulatory and clinical strategy 
• Conducting audits
• Preparing technical documentation incl.:
  • Risk management
  •  Usability engineering
  • Software documentation
  • Clinical evaluation
  • Biological evaluation 
  • Post-market surveillance reports
• Consulting on standards such as e.g.e.g. IEC 60601-1, IEC 62304 and IEC 62366
• Training

• Regulatory Affairs, 
• Clinical Affairs, 
• Quality Management, 
• Medical Devices, 
• In vitro Diagnostic Devices