Design control milestones
  • Prior art search and non infringement studies

  • Invention disclosure

  • Voice of the Customer methodology (VOC)

  • Users Requirements Analysis to define Uses Specifications

  • Device System and Sub-system analysis

  • Risks Management

  • Prototyping and Bench Testing

  • Design Reviews

  • Verification & Validation, Design Transfer

  • Project Management fulfilling Medical Devices Regulations:

  • Design Control and DHF filing

  • Definition of Regulatory Affairs data from Design

 
 
Gemar can assist you at every step of RA activities
  • Regulatory Strategies in EU and RoW
  • Global Regulatory Consulting for Medical Device and IVD
  • Regulatory Gap Analysis
  • Creation of a Regulatory Dossiers
  • Global Medical Device Registration and Approval
  • EC Representative service (AR) 
  • US agent service
Feel free to contact us and see how we can assist you.