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confinis ag
Switzerland
Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards

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confinis ag is a Swiss consulting firm founded in 2005 and headquartered in Dödingen, Canton of Fribourg, specializing in regulatory affairs, quality management, and compliance solutions for medical devices, in vitro diagnostics (IVD), and combination products. In October 2025, confinis joined the athagoras Life Sciences platform to enhance its international regulatory reach across Europe and North America.

The company supports developers, manufacturers, and startups through all design-level compliance phases required to achieve market clearance, including CE marking under European regulations and FDA authorizations in the United States. Its team combines technical, clinical, and regulatory backgrounds to align product development with stringent international standards.

Offer

confinis ag delivers end-to-end regulatory and quality consulting services across the product lifecycle:

  • Design Controls & Technical Files: Development and audit of Design History Files (DHF) and Device Master Records (DMR) conforming to FDA 21 CFR Part 820 / QMSR and ISO 13485:2016.
  • CE Marking & Global Submissions: Authoring technical documentation for CE conformity assessment under EU MDR 2017/745 and IVDR 2017/746; preparation of US FDA submissions, including 510(k), De Novo classifications, and PMA filings.
  • Risk Management & Usability: Execution of ISO 14971-compliant risk management processes and IEC 62366-compliant usability engineering files.
  • Software & AI Compliance: Lifecycle documentation for Software as a Medical Device (SaMD) and adaptive machine learning devices in compliance with IEC 62304 and emerging regulatory frameworks.
  • Combination Products: Assessment and documentation according to EU MDR Article 117 requirements for drug-device combinations.
  • Testing Laboratory Liaison: Coordination and protocol development with accredited testing facilities for electrical safety, biocompatibility, and EMC verifications.

Tags

ce marking
iso 13485
ivdr
regulatory affairs
fda submissions
risk management
design controls
samd
Industrial Specializations: Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards
Headquarter/main address: Hauptstrasse 16
Dödingen
Fribourg 3186
Switzerland
https://confinis.com
Business Type: Service Provider
Ownership: Subsidiary
Employees: 10 - 49
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