Who We Are
Medical Devices Regulatory Consultancy
Breaking Barriers for Complex Markets
OMC Medical is primarily based in the UK with offices around the globe offering regulatory support to medical device manufacturers; Offering assistance starting from medical device design requirements in accordance to the relevant applicable standards, obtain relevant MoH certification or listings, establishing your devices in a new market, keep product licenses up to date until the product is End of Service (EOS).
Our team specializes in Regulatory Affairs supporting with global regulations(CE, FDA, UKCA, MedDo, CDSCO, NMPA) and local product registrations across the globe, thereby saving the time spent on research and conflicting requirements.
Our motto is to “break the complex barriers” and making the regulatory environment feasible to operate. We support you in all stages of product development analyzing global strategy, implications, and implementation of changes.
We support all medical device organisations, from start-ups to multinational organisations, with cost-effective regulatory solutions. We have experts from the computer field to support Software as a Medical Device (SaMD), Biomedical Engineers with medical device knowledge and industry experience.