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

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Congenius AG is a Swiss medical technology consulting firm founded in 2016 and headquartered in Dietikon (Canton of Zurich). The company has successfully executed hundreds of projects across the life sciences industry, offering consulting expertise structured into five key excellence areas: Quality, Regulatory, eHealth, Operations, and Clinical.

Congenius assists medical device, IVD, and pharmaceutical companies in overcoming regulatory hurdles right from early development through post-market surveillance. Its consultants deliver design-level preparation, compiling technical documentation required for European CE marking under MDR/IVDR as well as FDA clearance in the United States.

Offer

Congenius AG offers a full range of consulting services across design controls, operations, and regulatory clearance:

  • Regulatory Compliance Strategy: Development of pathway strategies and compliance documentation for global market entry, including CE marking under EU MDR/IVDR and US FDA submissions.
  • Design History & Technical Dossiers: Preparation and restructuring of Design History Files (DHF), Device Master Records (DMR), and General Safety & Performance Requirements (GSPR) documentation.
  • Quality Engineering & Validation: Planning and execution of process validation, equipment and infrastructure qualification (IQ/OQ/PQ), and test method validation including Measurement Systems Analysis (MSA).
  • eHealth & Digital Health Solutions: Technical documentation and regulatory support for Software as a Medical Device (SaMD), digital health applications, and AI/ML algorithms in healthcare.
  • Quality Management Systems (QMS): Setup, remediation, and audits for compliance with ISO 13485:2016 and FDA 21 CFR Part 820.
  • Clinical Affairs: Clinical evaluation planning, Clinical Evaluation Reports (CER) according to MDR Annex XIV, and post-market clinical follow-up (PMCF) plans.

Tags

ce marking
iso 13485
regulatory affairs
fda submissions
design history file
process validation
medtech consulting
Industrial Specializations: Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards
Headquarter/main address: Riedstrasse 1
Dietikon
Zürich 8953
Switzerland
Get Directions
https://congenius.ch
Business Type: Service Provider
Ownership: Private
Employees: 10 - 49
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