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).
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. The purpose of these requirements is to demonstrate that products are safe and effective prior to clinical use.
OMC Medical offers regulatory support to assist MedTech companies in ensuring the safe and effective use of medical devices for local and international markets. We assist you right from design and development to analysing the regulatory compliance requirements.
Next is the manufacturing stage, up until the post-market stage for medical device approval. Our primary objective is to provide end-to-end regulatory solutions that enable medical device manufacturers to deliver exceptional health care with cost-effective solutions.
We have a team of experts specialising in Medical Engineering, Software as a Medical Device (SaMD), with several years of medical device regulatory industry experience.
We could deliver projects for you with short deadlines and assist you in meeting your targets within the deadline.
We care about our clients; we work with you on your budget to provide a suitable solution for both parties. We pride ourselves in providing service better than industry standards.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.