OMC Medical
Breaking Barriers for Complex Markets
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 industry 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
MDCG Guidance for Manufacturers of Class I Medical Devices
This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market in order to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.
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
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.
