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DirectoryIndustryMedical Technology IndustryBernDecomplix AG
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Decomplix AG

Summary

About the company

The Decomplix AG supports customers in the approval and market access of medical devices, particularly in the field of software for medical devices. The core activities include the creation of regulatory strategies, the implementation of risk classifications, compliance with quality management and compliance requirements, as well as support in CE certification. Decomplix offers its customers individually tailored services to simplify and accelerate market access for medical devices.

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Products & services

Industry:Medical Technology Industry
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CE conformity assessment for medical devices
CE certification for medical devices, including situational analysis, interactive workshops, regulatory consulting, quality management, and support throughout the entire conformity assessment process.
Swiss Authorised Representative (CH-REP)
CH-REP service for medical device and IVD manufacturers outside Switzerland, including market access, Swissmedic communications, vigilance reporting, document review, and labelling review.
Compliance for importing medical devices into Switzerland
Advisory, training, and templates for the compliant import of medical devices and IVDs into Switzerland, including gap analysis, implementation, quality system, and ongoing support.
CE-certified medical device software (Evidencio)
CE certification for medical device software via the Evidencio platform, including pre-assessment, technical documentation, clinical evidence, and onboarding of an algorithm.
Swissmedic inspection readiness check for importers
Pragmatic readiness check for Swissmedic inspections of Swiss importers, including planning, simulated audit, document review, interview phase, reporting, and a remediation action plan.

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Location

Freiburgstrasse 3
3010 Bern
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-150.315.179
Founded
2016 · 10 years
Last commercial register change
September 29, 2025
Employees
11 to 20

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