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  • confinis launches new UK Responsible Person service in UK
    October 11, 2021
  • ISO/FDIS 11608 series opened for voting
    October 8, 2021
  • confinis partners with Irdeto to launch the first cybersecurity assessment tool in the medical devices industry
    July 6, 2021
  • confinis offers Swiss Representative Service
    June 18, 2021
  • Exporting Swiss Medical Devices to the EU
    May 26, 2021
  • Join our Startup Workshop 2021!
    April 24, 2021
  • … and Report your Post-Market Clinical Follow-up Evaluation!
    April 23, 2021
  • How to plan your post-market clinical follow up…
    March 10, 2021
  • How does the notified body assess your clinical evaluation?
    February 18, 2021
  • How to perform a clinical evaluation for Medical Device Software
    January 28, 2021
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The confinis Blog

Welcome to the confinis blog. This is the place where we are writing about news, events and helpful information. Enjoy.

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Combination Products Services

  • MDR Article 117
  • Combination Products
  • Design Control
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In-Vitro Diagnostics

  • New IVDR
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Product Development Services

  • Digital Health
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  • Combination Products
  • DHF Remediation
  • Software Validation
  • Mobile Medical Apps
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QM, Auditing & Training Services

  • eQMS
  • Quality Management System
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  • Training
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  • 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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