OMC Medical (EUAR)
EU Authorized Representative
Need an EU Authorized Representative? OMC supports MDR/IVDR compliance for medical devices in the US, UK, China, Japan, Mexico, and more
Osmania Medical College, founded in 1919, is a distinguished institution in Hyderabad, India, with a legacy rooted in the Hyderabad Medical School established in 1846. The college is committed to advancing medical education, fostering research, and providing high-quality patient care. It boasts a world-class faculty, modern facilities, and a vibrant academic atmosphere that encourages continuous learning. The institution has a rich history, tracing its origins back to the 16th century with the founding of 'Darush-Shifa'. Over the centuries, it has evolved into a leading medical college, contributing significantly to the healthcare landscape of Hyderabad and beyond. Osmania Medical College is ISO certified and has achieved a NIRF ranking of 48, underscoring its commitment to quality and academic excellence.
About
**Who they are**
OMC Medical (EUAR) is a provider supporting compliance for medical devices and in vitro diagnostic (IVD) devices. They assist with navigating regulatory requirements for global market entry.
**Expertise & scope**
* Support for Medical Device & IVD product registration, including acting as an Authorized Representative.
* Assistance with ISO 13485 and Quality Management System (QMS) implementation and support.
* Services for cosmetics, including product registration, notification, acting as an agent, claims support, and GMP compliance.
* Support for pharmaceutical product registration, market authorization, and GMP compliance.
* Translation and localization services.
* Conducts ongoing supplier audits to ensure adherence to specifications and regulatory standards, covering quality management, documentation, and record-keeping.
**Reputation / proof points**
* Certified to ISO 13485:2016.
* Certified to ISO 17100:2015 (for translation services).
OMC Medical (EUAR) is a provider supporting compliance for medical devices and in vitro diagnostic (IVD) devices. They assist with navigating regulatory requirements for global market entry.
**Expertise & scope**
* Support for Medical Device & IVD product registration, including acting as an Authorized Representative.
* Assistance with ISO 13485 and Quality Management System (QMS) implementation and support.
* Services for cosmetics, including product registration, notification, acting as an agent, claims support, and GMP compliance.
* Support for pharmaceutical product registration, market authorization, and GMP compliance.
* Translation and localization services.
* Conducts ongoing supplier audits to ensure adherence to specifications and regulatory standards, covering quality management, documentation, and record-keeping.
**Reputation / proof points**
* Certified to ISO 13485:2016.
* Certified to ISO 17100:2015 (for translation services).
Additional information
OMC Medical (EUAR) facilitates market access for medical devices and IVDs by ensuring compliance with national regulatory requirements. Their services extend to cosmetics and pharmaceuticals, offering product registration, notification, and acting as an agent or market authorization holder. They also provide translation and localization services, crucial for global product launches. Buyers should note that OMC Medical (EUAR) conducts thorough supplier audits as part of their quality assurance process, ensuring that all aspects of a supplier's QMS, including documentation and record-keeping, meet required standards.
Key Highlights
-
Provides EU Authorized Representative services for medical devices and IVDs.
Source
“공인 대리인”
-
Offers support for ISO 13485 and QMS.
Source
“ISO 13485 및 QMS 지원”
-
Provides services for cosmetics, including product registration and acting as an agent.
Source
“화장품 제품 등록 및 신고 대리인”
-
Certified to ISO 13485:2016.
Source
“ISO 13485:2016 인증”
-
Certified to ISO 17100:2015 for translation services.
Source
“ISO 17100:2015 인증”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking EU Authorized Representative services for medical devices and IVDs.
- Businesses needing support with product registration and regulatory compliance in international markets.
- Firms requiring assistance with QMS implementation and ISO 13485 certification.
How engagement typically works
- Partnership for global market entry.
- Support for regulatory compliance and product registration.
- Auditing and quality management assistance.
Typical deliverables
- Designated EU Authorized Representative.
- Product registration documentation.
- QMS documentation and support.
- Translation and localization services.
Good to know
- Best when requiring specialized support for medical devices, IVDs, cosmetics, or pharmaceuticals in international markets.
HQ:
Hyderabad, IN
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Find EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK
Countries:
IE, GB, DE, FR, NL
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 3,200
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
EU Entity Country:
EU
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
Labeling Review:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
Yes
Post Market Support
Yes
Vigilance Contact Support
Implied through Authorized Representative role.
⚡ Instant booking available
Appoint an EU MDR Authorized Representative in Minutes
Compare OMC Medical (EUAR) and other vetted providers — instant pricing, no RFQ needed.
