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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint745,701 companies indexed · Last updated: today
DirectoryIndustryMedical Technology IndustryDüdingenconfinis ch-rep ag
confinis ch-rep ag Logo
Verified· 3 sourcesTrust Score
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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3.8/5

confinis ch-rep ag

✓ Offered12
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.
Postmarket Surveillance
Postmarket surveillance for medical devices and combination products; planning of PMCF studies, literature analyses, market monitoring and updating of clinical evaluations.
Performance Evaluation
Performance evaluation for IVD devices; scientific literature search, expert assessments, studies and ongoing updating of documentation.
Classification and Regulatory Strategy
Classification and regulatory strategy for medical devices, IVD, software and laboratory equipment; regulatory classification, path selection and market strategy.
CE marking, FDA and global product registrations
Support for CE marking, FDA approvals and global product registrations; technical dossiers, submissions and interaction with authorities.
Evaluation and Monitoring of Applicable Regulations, Standards, and Guidances
Ongoing monitoring of relevant regulations, standards and guidance documents; assessment of changes and their impact on products and operations.
Interaction with Competent Authorities (e.g., FDA, EMA)
Communication with the FDA, EMA and other authorities; preparation of meetings, answering follow-up questions and support with submissions.
MDR Art 117
Preparation and review of technical documentation according to MDR Article 117 for combination products; submission to the Notified Body for an opinion.
Trust & reputation

ranQ Trust Score of confinis ch-rep ag: 3.8 out of 5.0

Trust Score3.8/ 5.0

High

x

Data basis 96% · As of October 2026

confinis ch-rep ag scores 49.8 out of 100 points in the Reputation area of the ranQ Trust Score. This area carries 42% of the weighting.
x
CriterionValueWeight
  • Review quality: The average rating across all connected sources, smoothed against the industry mean. So 5.0 stars from three reviews do not outrank 4.7 from three hundred.68.224%
  • Review volume: The number of reviews across all sources. The scale is logarithmic: the first reviews count the most, and the maximum is reached at 50 reviews.17.610%
  • Review recency: The age of the most recent review. Two-year-old reviews deliberately sit in the middle, because that is normal for Swiss SMEs. Only after three years without a new voice does the value drop markedly.35.08%
confinis ch-rep ag scores 74.1 out of 100 points in the Substance area of the ranQ Trust Score. This area carries 28% of the weighting.
x
CriterionValueWeight
  • Establishment: Years since founding or brand launch, logarithmic. The maximum is reached at 15 years.64.612%
  • Company size: The headcount band, researched by ranQ or stated by the company. It is scored in steps rather than by head count, because the data only provides bands.70.07%
confinis ch-rep ag scores 85.0 out of 100 points in the Identity area of the ranQ Trust Score. This area carries 22% of the weighting.
x
CriterionValueWeight
  • Verification: Official register entry (commercial register with UID or professional-body record, 55 points), confirmed domain (20 points) and confirmed ranQ profile (up to 25 points, depending on completeness).85.022%
confinis ch-rep ag scores 62.9 out of 100 points in the Visibility area of the ranQ Trust Score. This area carries 8% of the weighting.
x
CriterionValueWeight
  • Website authority: Ahrefs' Domain Rating measures, on a scale of 0 to 100, how strongly a website is linked from other websites. For Swiss SMEs the range up to 40 is typical; the maximum is reached at 35.62.94%
  • Media authority: No data point — the criterion is taken out of the weighting and does not lower the score.—4%
Qualifications+0.00

confinis ch-rep ag reaches a ranQ Trust Score of 3.8 out of 5.0 — rated «High». The rating draws, among other things, on 5.0 out of 5 stars from 1 customer reviews. The data basis is 96%, so the score is backed by part of the criteria. As of October 2026.

The Trust Score cannot be bought and is calculated from publicly verifiable data.

Reviews

Aggregated rating

Aggregated rating
5
of 5

Aggregated from 1 reviews across all connected sources

Sources
GGoogle51
★TrustpilotSoon
PProvenExpertSoon

Further sources are added continuously and factored into the ranQ Rating.

Knowledge

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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
September 21, 2026
Employees
11 to 20
Legal form: Graded by liability and disclosure. The weight is kept small: a sole proprietorship is not a dubious company, it is just liable differently.
100.0
6%
  • Branch offices: Branch offices linked in the commercial register. Having none is normal and costs no points.70.03%
    • Full methodology

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