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.
News and Updates
Swissmedic information sheet on systems and procedure packs
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
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
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 [...]
