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Medical Device & IVD

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Medical Device & IVD

Empowering Healthcare Through Innovation

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).

What We Offer

We provide and combine multiple services that are tailored to your business requirements by removing the complexity and unnecessary cost of getting multiple parties involved.
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Regulatory Compliance

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Quality Assurance

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Global Translation

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Importer Services

To understand more about the services, we offer please click below to view all our services. All our services are bound to ISO 13485 Standards.

Launch a Medical Device

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.

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Elevating Healthcare Through Exceptional Medical Device Manufacturing

we pride ourselves on being at the forefront of medical device innovation. Our commitment to cutting-edge technology ensures that the devices we manufacture are at the pinnacle of quality, efficiency, and reliability.
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Core Features

Knowledge & Quality

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.

Reliable & On Time

We could deliver projects for you with short deadlines and assist you in meeting your targets within the deadline.

Cost-effective  Solutions

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.

Why Choose Us?

Cost Effective

Attention to Detail

Global Know How

True Partners

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