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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint744,924 companies indexed · Last updated: today
DirectoryIndustryMedical Technology IndustryDietikonCongenius AG
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Congenius AG

Summary

About the company

The company Congenius AG is a consulting firm specializing in the areas of medical technology (MedTech), healthcare (eHealth), and life sciences. The company's core activities include: * Consulting and support in the development and implementation of quality management systems (QMS) * Regulatory Affairs and technical documentation * Process optimization and engineering * Product development and safety * Clinical trials and research * Support in complying with regulatory requirements and standards (e.g. 21 CFR 820, MDR, ISO 13485) The company offers its services to companies in the medical technology, pharmaceutical, and healthcare industries, supporting them in addressing challenges in the areas of quality, regulatory affairs, and product development.

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Products & services

Industry:Medical Technology Industry
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✓ Offered8
Quality Consulting
Quality management, quality engineering and quality assurance for MedTech and IVD companies; QMS optimisation, audits, supplier and distributor quality, risk management, usability, design verification and labelling.
Regulatory Consulting
Regulatory strategy, technical compliance, worldwide registrations and post-market surveillance for MedTech and pharmaceutical firms; plus GSPR support, technical dossiers, CE and FDA registrations, reimbursement and sustainability compliance.
eHealth Consulting
Consulting for medical device software and SaMD/SiMD; requirements management, risk and cybersecurity management, lifecycle management, usability, project management, data privacy and design controls.
Operations Consulting
Consulting for manufacturing and operational processes in MedTech; process engineering, biocompatibility, sterility and product cleanliness, equipment and infrastructure qualification, process validation, test method validation and quality control.
Clinical Consulting
Clinical strategy, clinical evaluation and clinical investigations for medical devices; including CEP/CER, PMCF planning, SSCP and documentation for authority and ethics submissions.

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Location

Riedstrasse 1
8953 Dietikon
Opening hours
Mon
08:00 - 18:00
Tue
08:00 - 18:00
Wed
08:00 - 18:00
Thu
08:00 - 18:00
Fri
08:00 - 18:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Corporation
UID
CHE-405.699.171
Founded
2016 · 10 years
Last commercial register change
July 4, 2024
Employees
11 to 20

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