Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Articles

Home
Blog Standard
Page 6
20Mar 2025
Events admin

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 Uninterrupted Market Access Solutions  SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 14 to March 17, 2024. The event, one of the largest medical exhibitions in As...
Read More
China International Medical Equipment Fair
20Mar 2025
Events admin

China International Medical Equipment Fair

CMEF, 2024 The China International Medical Equipment Fair (CMEF) is one of the largest and most influential medical equipment exhibitions in Asia, bringing together healthcare professionals, manufacturers, distributors, and innovators from around the world. Held biannually, CMEF showcases a wide array of medical devices, diagnostics, imaging systems, wearables, and other healthcare solutions. It serves as a platform for product launches, industry networking, and gaining insights into advancement...
Read More
kimes busan
20Mar 2025
Events admin

KIMES Busan Medical & Hospital Equipment Show

The KIMES Busan Medical & Hospital Equipment Show is a premier event in South Korea’s medical industry, showcasing the latest advancements in medical technology, hospital equipment, and healthcare solutions. Held annually in Busan, KIMES Busan attracts healthcare professionals, medical equipment manufacturers, and industry leaders from around the world, creating an ideal platform for networking, discovering new technologies, and expanding knowledge in the healthcare sector. Key Highlights...
Read More
arab health
20Mar 2025
Events admin

Arab Health Event 2025

OMC Medical Limited invites you to meet our team 𝑬𝒅𝒘𝒂𝒓𝒅 𝑪𝒉𝒆𝒏, 𝑵𝒊𝒌𝒐𝒍𝒐𝒂𝒔 𝑷𝒂𝒓𝒅𝒂𝒍𝒊𝒔 and 𝑪𝒉𝒊𝒅 𝑹𝒂𝒅𝒉𝒂𝒌𝒓𝒊𝒔𝒉𝒏𝒂𝒏 of Medical Device Regulatory Experts at one of the most prestigious healthcare events in the world, Arab Health 2025. Arab Health Event OMC Offer? Medical Devices & IVDs ✔ Product Registration✔ Authorized Representative Services✔ Support for Start-ups✔ Pro...
Read More
Quality Assurance for Medical Equipment in UAE
19Mar 2025
UAE, Blogs, Trending Now admin

Quality Assurance for Medical Equipment in the UAE 

The UAE has become a healthcare hub in the Middle East, with hospitals and clinics adopting advanced medical technologies. To maintain the highest standards in patient care, medical equipment quality assurance in UAE is a crucial focus area, ensuring that all devices used in clinical settings are safe, reliable, and effective.  The Importance of Medical Device Quality Assurance  Medical device quality assurances in UAE ensure that equipment used across healthcare institutions complies...
Read More
18Mar 2025
FDA, USA Cubicdesignz

FDA’s 510(K) Submission Process

The FDA 510(K) Pre-market notification submission as per 21 CFR 807 Subpart E is to be adopted by manufacturers to receive FDA clearance to market medical devices or for commercial distribution in the U.S. This review is done by FDA’s Centre for Devices and Radiological Health (CDRH). A 510(K) submission allows medical devices to be “FDA Cleared” and not FDA Approved. The route to 510(K) must be carefully investigated by the manufacturer through a step-by-step process which allows determin...
Read More
What is PIF in UAE
18Mar 2025
Blogs, Trending Now, UAE admin

What is a Product Information File (PIF) in UAE ? 

Bringing pharmaceutical products to market in the UAE requires more than just quality manufacturing — it demands strict compliance with local regulatory requirements. One of the essential components in this process is the Product Information File (PIF), a detailed dossier that provides regulators with key information about a product’s composition, safety, efficacy, and more.  While commonly associated with cosmetics, the PIF is also critical for pharmaceuticals in the UAE and serves as a ce...
Read More
Saudi Arabia’s SaMD regulations
13Mar 2025
Blogs, Saudi Arabia, Trending Now admin

How Saudi Arabia Regulates Software as a Medical Device (SaMD)? 

In recent years, Saudi Arabia has recognized the pivotal role of digital health solutions in modern healthcare. Central to this digital transformation is the regulation of Software as a Medical Device (SaMD). The Saudi Food and Drug Authority (SFDA) has established comprehensive guidelines, such as MDS-G23  Guidance on Software as a Medical Device, to ensure that SaMD products meet stringent safety and efficacy standards before entering the Saudi market.  Understanding SaMD  Softw...
Read More
How ISO 13485 Certification Supports SFDA Medical Device Approval
12Mar 2025
Blogs, Medical Device, SFDA, Trending Now admin

How ISO 13485 Certification Support SFDA Medical Device Approval? 

ISO 13485 certification is a crucial step in getting your medical device approved by the SFDA (Saudi Food and Drug Authority). It shows that your product meets high-quality standards and helps speed up the approval process. In this article, we’ll explain how this certification can help you meet SFDA requirements and get your device to market more quickly.  Let’s get started! Understanding ISO 13485 Certification  ISO 13485 is an internationally recognized standard that outlines...
Read More
10Mar 2025
Regulations Cubicdesignz

UK Medical Device Regulation

UK Medical Device Regulations Role of MHRA UK Approved Bodies Authorised Representatives Importer & Distributor Registrations in Great Britain Registration Data • Copy of Declaration of Conformity• E-copy of technical documentation• Device Certificate as granted by the Notified Body• Quality Management Certificate• Database information Manufacturing details• Letter of Designation• Contact persons and list of importers• Database information Device Details• Database informati...
Read More

Enquiry Now

    This will close in 0 seconds