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DirectoryIndustryMedical Technology IndustryDüdingenconfinis ch-rep ag
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confinis ch-rep ag

Summary

About the company

confinis ch-rep 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, cybersecurity assessments, a Swiss representative service and an e-learning platform (confinis Academy).

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Products & services

Industry:Medical Technology Industry
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CH REP, UK REP, US AGENT to the FDA
Representation services for Switzerland, the United Kingdom and the USA; official representative role, communication with authorities and ongoing regulatory support.
EUDAMED and swissdamed
Registration support for EUDAMED and swissdamed; support throughout the registration of medical devices in the EU and in Switzerland.
Person Responsible for Regulatory Compliance (PRRC)
PRRC services for medical devices and regulatory compliance; ongoing support for compliance programmes, risk management and regulatory obligations.
Technical Documentation Files Drafting
Drafting technical documentation dossiers for regulatory submissions; compilation of design, manufacturing and quality documentation.
Clinical Evaluation
Clinical evaluations for medical devices; analysis of clinical data, literature, clinical experience, and preparation and updating of reports.
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-336.658.658
Founded
2021 · 5 years
Last commercial register change
November 26, 2025
Employees
11 to 20

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