CMC Medical Devices home2025-02-20T13:32:28+00:00

In country representation and global consulting for medical devices

We offer personalized services that enable medical device manufacturers to achieve regulatory compliance and market access in any country with the most satisfactory solution.

In country representation and global consulting for medical devices

We offer personalized services that enable medical device manufacturers to achieve regulatory compliance and market access in any country with the most satisfactory solution.

CMC CONSULTING GROUP is an international group of consulting firms focused on regulatory affairs for medical devices.

Based in Spain, it has established various offices in the United Kingdom, Spain, Switzerland, China, Australia, and the USA. With professional technical teams from various fields around the world, it can provide personalized services for international clients based on the actual conditions of the manufacturer.

Committed to becoming the most reliable leading consultancy service provider for medical devices in the international market.

Our Services

News and Updates

Swissmedic information sheet on systems and procedure packs

August 14, 2025|

From 4 August 2025, Swissmedic clarifies the obligations for systems and procedure packs (SPPs) containing at least one medical device in Switzerland and Liechtenstein, under the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). [...]

FDA MDUFA Small Business Benefits: eligibility and reduced fee options

August 12, 2025|

The Medical Device User Fee Amendments (MDUFA) authorize the FDA to collect user fees for certain types of medical device submissions and for the annual establishment registration. For small companies in the sector, these costs can be reduced—or in [...]

MDR and IVDR Certification: Key Insights from the 14th NB Survey

August 7, 2025|

The availability of medical devices in the EU is closely linked to the certification capacity of Notified Bodies (NBs). To monitor this dynamic, the European Commission launched a recurring survey collecting data from all designated NBs under the MDR and [...]

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