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21. July 2022
Spotlight Life Cycle Management in Medical Technology

Life Cycle management tool support in the field of medical technology

Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
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Regulatory Affairs

  • Regulatory documentation and support worldwide
  • CE Marking: MDR & IVDR
  • Technical Documentation Europe
  • Regulatory Updates
  • Responsible person according to Article 15 MDR
  • Aktenfuchs
  • Market access strategies
  • qtec EuRep GmbH
  • qtec CE-Med GmbH
  • qtec TrendReport

Quality Management

  • Quality Management System
  • QM International
  • Further Management Systems
  • Audit Management
  • Audit Support
  • QMS-Software Validation
  • Software Life Cycle Processes

Design Control

  • Requirements Engineering and Management
  • Risk Management
  • Usability
  • Software Quality Assurance
  • Cybersecurity and Artificial Intelligence
  • Verification
  • Validation
  • Biocompatibility for
    Medical Devices

Clinical Affairs

  • Clinical Packages
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Our expert video series goes into the 8th round

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Our expert video series goes into the 9th round

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