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  • info@omcmedical.co.uk
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regulatory support
Medical Devices & IVD
Cosmetic & Pharmaceuticals
Cosmetic & Pharmaceuticals
Translations
Translations
Authorized Representative
Authorized Representative
https://omcmedical.com/medical-device-ivd-2/

Medical Device & IVD

cosmetic & Pharmaceuticals

Cosmetics & Pharmaceuticals

Authorised Representative

Translations

WELCOME TO OMC MEDICAL

Pioneering Progress in Medical Technology

OMC Medical is primarily based in the UK  with offices around the globe offering regulatory support to medical device manufacturers.

  • Medical Devices & IVD
  • Global Translation Services
  • Global Cosmetics Registration
  • Regularity Complainces
More About Us
medical device and ivd
medical device and ivd

OMC Medical: Global Regulatory Support for Medical Devices & Cosmetics

OMC Medical Limited consistently strives to meet customer expectations and is committed to satisfying its customers by delivering services with the required degree of perfection in relation to predetermined standards and sections. Customer satisfaction is vital to our business, and we have adopted unique service quality objective strategies within our company. This philosophy guides how we interact with our employees and clients and underscores the importance of our commitment to quality. These processes also enable our customers to provide their perceptions and satisfaction on activities performed. This information is used proactively to drive improvement within our business. We shall always strive to share a long-lasting and growing relationship with our customers. 

Additionally, we are proud to announce that our company is ISO 13485 certified for our processes and 17100 certified for translations. These certifications demonstrate our unwavering dedication to maintaining the highest standards of quality and excellence in all aspects of our operations.
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Find the Right Test for Your Needs!

Providing the Diverse Needs of Your Patient Community

Regularity Compliance

We are your trusted partner in navigating the complex landscape of regulatory compliance.

Translations Service

We understand the significance of clear, accurate, and culturally sensitive communication.

Cosmetic Registration

At Global Cosmetic Registration, we are dedicated to streamlining the complex process of cosmetic registration worldwide.

Medical Device & IVD

OMC Medical is primarily based in the UK with offices around the globe offering regulatory support to medical device manufacturers
Whether you are a provider or patient, when you need trusted information to make confident health decisions, consider us.

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.
View All Services

OUR PRESENCE

Multi-disciplinary engineering expertise

  • Building the future powered by innovation
  • Backed by highly skilled workforce
  • Exposure and expertise in diversified verticals
  • Focus on engineering excellence
  • Experience of building large scale projects

Spearheaded by a visionary

To quote Dr. A V S Raju, Padma Shri Awardee and the Founder Chairman Emeritus, NCC Limited, “At NCC, we follow the three fold path of hard work, tenacity and common sense. Because, we believe wisdom is common sense to an uncommon degree. So, we all are attuned to finding new solutions to challenges old and new.”
Clearly, the culture of commitment and diligence in our organization has been succinctly spelt out.

Strong foundation of values

To quote Dr. A V S Raju, Padma Shri Awardee and the Founder Chairman Emeritus, NCC Limited, “At NCC, we follow the three fold path of hard work, tenacity and common sense. Because, we believe wisdom is common sense to an uncommon degree. So, we all are attuned to finding new solutions to challenges old and new.”
Clearly, the culture of commitment and diligence in our organization has been succinctly spelt out.

Experience of building large scale projects

The veritable list of NCC’s clientele including both public sector undertakings and private sector institutions are clear indicators of its abilities to deliver large scale projects on time maintaining the highest quality standards.

Driven by innovation at every step

NCC’s holistic expertise stems from its constant dedication and pursuit of knowledge leading to innovative solutions to challenges. Belief in the talent, skill and commitment of the 11,000 employees coupled with training and development has been the reason for adoption/ improvisation of the latest technologies resulting in very satisfactory outcomes.

Focus on engineering excellence

Technically qualified engineers form the majority of the employees at both staff and line positions. The strong technological and engineering background lays the foundation for sound designs and impeccable implementation of projects. Keeping abreast of the latest developments in the field of construction, team NCC is always geared up to take initiatives for innovative designs and finding solutions to vexing problems.

Blogs

What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?  

In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requireme
Read More
2024 UK post-market surveillance (PMS) amendments

e-IFU Guidelines for Medical Devices in Saudi Arabia 

Imagine you're a healthcare professional in Riyadh, mid-procedure, and you urgently need access to a device's instructions. Instead of flipping through a bulky printed manual, you scan a QR code on the device.
Read More
eifu guidelines for medical devices in saudi

Saudi AR License Renewal Fees & Process for Medical Devices

Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulatory requirements is ensuring ti
Read More
Saudi AR License Renewal Fees Process

Events

Arab Health Event 2025

OMC Medical Limited invites you to meet our team 𝑬𝒅𝒘𝒂𝒓𝒅 𝑪
arab health

KIMES Busan Medical & Hospital Equipment Show

The KIMES Busan Medical & Hospital Equipment Show is a premier event in Sou
kimes busan

China International Medical Equipment Fair

CMEF, 2024 The China International Medical Equipment Fair (CMEF) is one of t
China International Medical Equipment Fair

Bio Korea 2024 – The Future of Biotechnology Innovation and Global Collaboration

Every year, BIO KOREA organizes the International Convention with the goal of p
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OMC Medical to Showcase Global Market Access Solutions at KIMES 2024 

OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for
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ARAB Health Event – Unlocking Global Markets

The ARAB Health Event is back and ready to pave the way for groundbreaking advan
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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.

News

Clinical Evaluation vs Clinical Study
04Feb 2025
Blogs, Regulations, Trending Now admin

Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation? 

In the medical device industry, the terms clinical study and clinical evaluation are often used interchangeably—yet they serve very different purposes. Understanding the distinction between the two is crucial for manufacturers...
Clinical Evaluation vs Clinical Study
April 10, 2025 admin

Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation? 

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March 10, 2025 Cubicdesignz

Software As a Medical Device and Its Clinical Evaluation

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March 20, 2025 Cubicdesignz

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

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October 28, 2024 Cubicdesignz

Article 61 Clinical Evaluation in the EU MDR

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October 28, 2024 Cubicdesignz

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Testimonials

Proactively revolutionize granular customer service after pandemic internal or “organic” sources istinctively impact proactive human

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.
AnonymousRegulatory Specialist
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.
UK Responsible Person Miriam, Head of Quality Management and Regulatory Affairs
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.
Dr. Mat, CEO
I am impressed by the speed that OMC Medical responds to customer requests. Very knowledgeable staff.
UKRP, Swiss AR and Swiss Importer Anonymous, RA/QA Manager
OMC Medical were able to customize a solution that works well with our needs
AnonymousHead of Quality and Regulatory Affairs
Flexible and service-minded.
AnonymousHead of Quality and Regulatory Affairs
Very smooth to work with OMC medical, always helpful and eager to help..
AnonymousDirector, Quality and Regulatory
Previous
Next
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.
AnonymousRegulatory Specialist
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.
UK Responsible Person Miriam, Head of Quality Management and Regulatory Affairs
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.
Dr. Mat, CEO
I am impressed by the speed that OMC Medical responds to customer requests. Very knowledgeable staff.
UKRP, Swiss AR and Swiss Importer Anonymous, RA/QA Manager
OMC Medical were able to customize a solution that works well with our needs
AnonymousHead of Quality and Regulatory Affairs
Flexible and service-minded.
AnonymousQuality and Lean Co-ordinator
Very smooth to work with OMC medical, always helpful and eager to help.
AnonymousDirector, Quality and Regulatory
Previous
Next

OUR PRESENCE

Encompassing diverse areas of construction pan India

NCC Limited has made a mark in the country as one of the largest listed companies in terms of revenue with proven expertise in buildings, transportation, water and environment, irrigation, electrical(T&D), mining and railways sectors. NCC Limited has expanded its footprint to have a pan India presence with offices across nine cities – Ahmedabad, Bengaluru, Chennai, Delhi, Lucknow, Mumbai, Pune, Kolkata, and Patna with headquarters located at Hyderabad.

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Our Clients

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150+ million

customers around the world.

5 continents

45+ countries.

3.1+ million

drivers and couriers.

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