OMC Medical

Breaking Barriers for Complex Markets

Authorised Representative Services

Authorised representative or responsible person is required to be appointed before you can sell in these markets. OMC and its affiliates can support you in most countries around the globe.

Global Translations

Different markets have different language requirements; we support all languages worldwide and translate using human translators with expertise in the medical field.

Importer Services

With the new medical device regulation, an importer must gain market access into EU and Swiss markets. An importer of records is required for access into the Great Britain markets.

Regulatory Compliances

Global regulatory compliance keeps you abreast, supports you in achieving regulatory compliance, and ensures market access.

Quality Assurances

We are supporting you with a systematic procedure according to the required standards.

Our Expertise

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 industrial standards.

About

OMC Medical

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).

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.

About

OMC Medical

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).

Launch a Medical Device

To launch a medical device in a country, medical devices must comply with the local country 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 safe and effective use of medical devices for local and international markets. We assist you right from design and development to analyse 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.

Features

What We Offer

We offer a spectrum of services to help our clients gain market access and compliance support. Everything from creating dossiers for compliance or creating a quality management system to work in more effective ways to suit, and training and updating your team with new regulations around the world, and helping you be abreast and in compliance to these new regulations.

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.

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.

Regulatory Compliance

Global regulatory compliance, keeping you abreast and supporting you achieve regulatory compliance and ensuring market access.

Quality Assurance

Supporting you with systematic procedure according to the required standards.

Global Translation

Different markets have different language requirements. We support all languages around the world and translate using Human translators with expertise in the medical field.

Importer Services

With the new medical device regulation, and Importer is required to gain market access to EU and Swiss markets. Furthermore, an Importer of Record is required for the Great Britain market.

Our Clients

Blogs

Latest Articles

MHRA Guidance on Stand-alone Software Medical Devices

MHRA Guidance on Stand-alone Software Medical Devices

Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation in the EU MDR

Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.

The ‘Blue Guide’ on EU product rules implementation 2022 

The ‘Blue Guide’ on EU product rules implementation 2022 

The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent...

What our clients are saying!

UK Responsible Person

We have worked with OMC Medical over a year and OMC serves us as UK Responsible Person and have found them to be supportive and informative team on this activity. Their team is quick to respond and action on our requirements.

OMC Medical is thorough on their process and takes time to understand our concerns and to answer our queries, we recommend OMC Medical to other medical device manufacturers. If you have any questions please free to contact us.

Miriam, Head of Quality Management and Regulatory Affairs

CE, UKCA, FDA Marking

I have worked, and I am still working, with OMC Medical for our medical device project. We have worked with OMC Medical to write technical documentation for our product which includes CE marking, FDA marking and UKCA marking. We strongly recommend OMC Medical to any other medical device manufacturers in the market to obtain regulatory certifications and other regulatory needs. OMC Medical has worked to tight deadlines and always to the highest quality.

Their knowledge and attention to detail with the changing regulatory scope has been very impressive. I feel confident in recommending OMC regulatory services. I have actually recommended them to 4 other clients in the past 3 months.
OMC Medical is not only thorough but also easy to work with and always willing to take the time to discuss my concerns and respond to questions.

Dr. Mat, CEO

UKRP, Swiss AR and Swiss Importer

I am impressed by the speed that OMC Medical responds to customer requests. Very knowledgeable staff.

Anonymous, RA/QA Manager

Swiss AR and Swiss Importer

Service minded. OMC Medical were able to customize a solution that works well with our needs.

Anonymous, Head of Quality and Regulatory Affairs 

Swiss AR

OMC Medical Team Consultants have been a big help in supporting our risk management activities to comply with EU MDR requirements for medical devices. They have demonstrated technical and compliance expertise, been responsive to time-sensitive projects, and conducted themselves collaboratively and professionally.

Anonymous, Regulatory Specialist

Swiss AR and Importer

Flexible and service-minded.

Anonymous, Quality and Lean Co-ordinator

Swiss AR

Very smooth to work with OMC medical, always helpful and eager to help.

Anonymous, Director, Quality and Regulatory

How can we help?

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OMC Medical can help you with all type of regulatory services. 

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