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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint742,806 companies indexed · Last updated: today
DirectoryBusiness & Technical ServicesManagement ConsultingDüdingenconfinis ag
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Verified· 3 sources

confinis ag

Summary

About the company

confinis ag is a global consulting firm focused on medical devices, in vitro diagnostics and combination products. It provides regulatory affairs and compliance services, quality management and clinical evaluation support, as well as specialist offerings such as Swiss representative and UK Responsible Person services, FDA expert matchmaking and an e‑learning platform (confinis Academy) to assist market authorisation and conformity processes.

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Regulatory Affairs
Regulatory affairs strategy, market authorisation planning and implementation support for medical devices, in vitro diagnostics and combination products in Europe, the USA and other markets.
Compliance
Compliance for medical devices, IVDR conformity, CE marking, FDA registrations, design control, risk management, usability engineering, clinical evaluation and performance evaluation.
Quality Management System (QMS)
Development and implementation of a QMS according to EN ISO 13485 and 21 CFR Part 820, including SOPs, Quality Manual, checklists, forms and KPI-supported implementation.
Swiss Representative Service
CH-REP and PRRC services for Swiss medical device manufacturers, including representation for the Swiss market and transitional arrangements depending on the product class.
Training and E-learning
E-learning and training programmes for professionals and startups on regulatory topics, with an online academy and topic-based courses.
Reviews

Aggregated rating

Aggregated rating
5
of 5

Aggregated from 1 reviews across all connected sources

Sources
GGoogle51
★TrustpilotSoon
PProvenExpertSoon

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Location

Hauptstrasse 16
3186 Düdingen
Opening hours
Mon
09:00 - 17:00
Tue
09:00 - 17:00
Wed
09:00 - 17:00
Thu
09:00 - 17:00
Fri
09:00 - 17:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Corporation
UID
CHE-112.198.642
Founded
2005 · 21 years
Last commercial register change
January 29, 2026
Employees
11 to 20

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