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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint745,041 companies indexed · Last updated: today
DirectoryIndustryMedical Technology IndustryRombachAXXOS AG
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AXXOS AG

Summary

About the company

The company's core activity is advising and supporting companies in the medical technology industry in implementing and optimizing quality management systems, conducting audits, and complying with regulatory requirements, particularly in the areas of FDA and ISO standards. The company also provides training, coaching, and consulting services in the areas of medical devices, plastics technology, metal industry, and cleaning technology.

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Offering

Products & services

Industry:Medical Technology Industry
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Regulatory Affairs
Regulatory consulting for medical devices, development process and V&V, risk management, MDR technical documentation, clinical evaluation, as well as approval strategies and submission files.
Quality Management Services
Support for quality management systems, computer system validation, qualification and validation, QMS for testing and calibration laboratories, and support for healthcare institutions.
EU MDR / CH MepV
Support for manufacturers, suppliers, importers and distributors regarding EU MDR and CH MepV, incl. EU/CH-REP, technical documentation, clinical evaluation and market surveillance.
FDA Services
Support for FDA readiness and inspections, FDA registration and US agent, as well as FDA submissions for manufacturers and suppliers.
Training and Courses
Training on medical technology topics with practical focus, pre- and post-work, workshops, and EDUQUA-certified instruction.
Gap Analyses and Internal Status Audits
Gap analyses and internal status audits for systematic preparation for requirements, inspections and regulatory deviations.
Standards and Laws Update Service
Update service for standards and laws, with ongoing information on regulatory changes in the medical technology environment.
Simulated Authority Inspection
Simulated Swissmedic inspection for importers and CH-REP, tailored on request and on site at your premises.
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Location

Baumschulweg 19
5022 Rombach

At a glance

Legal form
Corporation
UID
CHE-101.555.577
Founded
2000 · 26 years
Last commercial register change
May 18, 2026
Employees
11 to 20

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