OMC Medical Spolka

OMC Medical is a UK based company operating in Poland and other parts of the world offering a 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 their devices in new market, keep product licenses up to date until the product is End of Service (EOS).

Our Engineers are specialised in Regulatory Affairs for CE Marking and other product registrations across the globe thereby saving the time spent on research and conflicting information of 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 analysing 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 computer field to support Software as a Medical Device (SaMD), Biomedical Engineers with medical device knowledge and industry experience.