Switzerland
  • Switzerland
  • USA
  • confinis ag, Hauptstrasse 16, CH-3186 Düdingen, Switzerland
  • info.ch@confinis.com
  • +41 26 494 8 494
  • confinis corp., 4445 Willard Ave, Suite 600, Chevy Chase, MD 20815, USA
  • info.usa@confinis.com
  • +1 240 252 0891
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  • Switzerland Office
  • U.S. Office

Switzerland Office

Location

  • confinis ag, Hauptstrasse 16,
    CH-3186 Düdingen, Switzerland
  • +41 26 494 8 494
  • info.ch@confinis.com

Your contact

Beat Steffen
Beat U. Steffen
Founder & CEO
Email: info.ch@confinis.com

Send us a message

    U.S. Office

    Location

    • confinis corp., 4445 Willard Ave, Suite 600,
      Chevy Chase, MD 20815, USA
    • +1 240 252 0891
    • info.usa@confinis.com

    Your contact

    Viky Verna
    Viky Verna
    Co-Founder & President
    Email: info.usa@confinis.com

    Send us a message

      Combination Products Services

      • MDR Article 117
      • Combination Products
      • Design Control
      • Risk Management
      • Usability Engineering
      • Clinical Evaluation
      • 21 CFR Part 4

      In-Vitro Diagnostics

      • New IVDR
      • Classification and Regulatory Strategy
      • CE marking, FDA and global product registrations
      • Performance Evaluation
      • Software

      Product Development Services

      • Digital Health
      • Design Control
      • Risk Management
      • Usability Engineering
      • Clinical Evaluation
      • Regulatory Due Diligence
      • Combination Products
      • DHF Remediation
      • Software Validation
      • Mobile Medical Apps
      • Production & Process Optimization
      • Packaging

      QM, Auditing & Training Services

      • eQMS
      • Quality Management System
      • Design Control
      • Training
      • Auditing
      • Validation / Qualification
      • FDA Inspections
      • Postmarket Surveillance

      Regulatory Affairs & Market Authorization

      • Digital Health
      • Regulatory Affairs Strategy
      • Market Authorization in Europe
      • Market Authorization in the USA
      • Market Authorization in other Markets
      • EC Representative
      • US Agent
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