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DirectoryIndustryMedical Technology IndustryZugCMC Medical Devices GmbH
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CMC Medical Devices GmbH

Summary

About the company

The company provides consulting and services for medical device manufacturers, particularly in the areas of authorization, registration, and compliance. It acts as an authorized representative for medical device manufacturers in various countries, including the EU, UK, Switzerland, USA, Australia, and China. The core activities include: Registration and authorization of medical devices with the competent authorities; Consulting on compliance with regulatory requirements, such as MDR, IVDR, and ISO 13485; Post-marketing surveillance and market safety monitoring; Representation of medical device manufacturers in international markets. The company supports medical device manufacturers in fulfilling their regulatory obligations and helps them successfully place their products on the market.

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Industry:Medical Technology Industry
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Regulatory and compliance consulting for medical devices
Regulatory Affairs, compliance consulting and market access for medical devices and IVDs in international markets; support with regulatory requirements and approval conditions.
In-country Representation Services
Authorized Vertretungsdienste in various jurisdictions; EU REP, UK REP, CH REP, TGA Sponsor, FDA Agent and China REP for ongoing communication with authorities.
Global registration of medical devices
Registration services for market entry in Europe, UK, Switzerland, Australia, USA, China, Saudi Arabia, Korea, India and other markets in Asia and South America.
Consulting on MDR, IVDR and ISO 13485
Support with technical documentation under MDR and IVDR as well as establishing a quality management system according to ISO 13485:2016.
Consulting on manufacturing and import licenses
Support in obtaining manufacturing and import licences for medical devices and IVDs, including the AEMPS manufacturing licence and import licence.
EUDAMED and SWISSDAMED registration
Validation and support during registration in EUDAMED and SWISSDAMED as well as for UDI management for medical devices and IVDs.
Free Sale Certificate (FSC)
Support for the issuance of Free Sale Certificates for medical devices and IVD products for export and registration support.
Legal Importer
Acting as the legal importer in Europe for medical devices and IVDs, to ensure regulatory compliance and market access.
Import into Spain
Import service for medical devices and IVDs in Spain based on a valid import licence.
GPSR consulting
Advisory services to ensure compliance with the GPSR for safe and regulation-compliant access to the EU market.
Advisory services for Cosmetics, PPE and Legal Representative
Representation and advisory services for Cosmetics, PPE and Legal Representative in complementary regulatory contexts.
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Location

Rigistrasse 3
6300 Zug

At a glance

Legal form
Limited Liability Company
UID
CHE-484.802.757
Founded
2021 · 5 years
Last commercial register change
January 27, 2026
Employees
11 to 20

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