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

New EU regulation on e-IFU: what changes for medical devices?

July 3, 2025|

On 25 June 2025, the European Commission published a new regulation that allows all medical devices used by healthcare professionals in the EU to be accompanied by instructions for use (IFU) in electronic format. This update expands the use [...]

When does the AI Act apply to medical device software?

June 30, 2025|

The AI Act applies to software intended to fulfil a medical purpose, when it qualifies as an AI system and is part of a medical device or IVD subject to MDR or IVDR. Only those requiring a conformity assessment involving [...]

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