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
Conditional CE certificates: A new pathway for faster market access?
Over the past few years, the medical device industry has been navigating a complex regulatory landscape with the implementation of MDR 2017/745 and IVDR 2017/746. While these regulations have strengthened safety and performance standards, they have also created a bottleneck [...]
Data integrity in medical device testing – A critical FDA concern
Why data integrity in medical device testing is more important than ever The FDA’s Center for Devices and Radiological Health (CDRH) has recently intensified its scrutiny of data integrity in medical device testing, and for good reason. The agency has [...]
AI and medical devices: The UK defines a new regulatory path
Artificial Intelligence is transforming the healthcare industry, providing increasingly sophisticated tools for diagnosis, monitoring, and treatment. However, with the rising adoption of AI-powered medical devices, ensuring safety and effectiveness has become a top priority. Recently, the UK government took a [...]
