Who we are?
Founded in January 2020 and based in Horsham, United Kingdom. OMC is trusted by our clients for our service and transparency. During the indecisive period of Brexit, many of our clients wanted a trusted partner to support them with the new UK regulations through which OMC formed new relationships and word of mouth referrals and started working with Novel device manufacturers.
To support our clients, we expanded both our team and locations, establishing ourselves and forming partnerships with like-minded organizations worldwide, offering global regulatory support to our clients. We have developed a vast network of contacts to support different regions, from local registrations to local representatives to gain market access.
Our team comprises experts from various fields of regulatory and quality assurance. With a strong team, we support our clients with multiple functions globally. We offer assistance starting from medical device design requirements according to the relevant applicable standards, obtaining 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). We specialize in Regulatory Affairs, supporting with global regulations (CE, FDA, UKCA, MedDo, CDSCO, NMPA), thereby saving the time spent on research and conflicting requirements.
Our motto is to “break the complex barriers” and make the regulatory environment feasible to operate. We support you in all stages of product development, analyzing global strategy, implications, and implementation of changes.
Our Mission and Vision
Breaking complex barriers
Our mission is to support our clients in launching their products in various markets, relieving them of complex procedures, and providing them with an effective regulatory strategy.
Safety to the community
By ensuring our clients follow compliance, we want to support them with additional measures to ensure the device is safe for the end-user.
The working culture around the world has changed with the pandemic, and we align ourselves with the new work culture and promote working from home and encourage this. We remotely manage our team, so our staff needs to be proactive and self-starters excelling in the field of teamwork remotely. With various tools, we have achieved harmony with our team.