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.
* Services include acting as an Authorized Representative.
* Assistance with ISO 13485 and Quality Management System (QMS) implementation.
* Guidance on cosmetic product registration and notification.
* Services for pharmaceutical product registration and market approval.
* Translation and localization services.
* Supplier audits focusing on quality management, documentation, and record-keeping.
* Support for GMP compliance in pharmaceuticals.
**Reputation / proof points**
* ISO 13485:2016 Certified.
* ISO 17100:2015 Certified.
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.
* Services include acting as an Authorized Representative.
* Assistance with ISO 13485 and Quality Management System (QMS) implementation.
* Guidance on cosmetic product registration and notification.
* Services for pharmaceutical product registration and market approval.
* Translation and localization services.
* Supplier audits focusing on quality management, documentation, and record-keeping.
* Support for GMP compliance in pharmaceuticals.
**Reputation / proof points**
* ISO 13485:2016 Certified.
* ISO 17100:2015 Certified.
Additional information
OMC Medical (EUAR) assists in ensuring products meet legal requirements, safety standards, and ingredient disclosure mandates, particularly for cosmetics regulated by bodies like the US FDA and European Union regulations. For medical devices, they act as a partner to facilitate entry into global markets by addressing the specific regulatory requirements of each country. Their services extend to supporting quality management systems and acting as a representative for various product categories including pharmaceuticals and cosmetics.
Key Highlights
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Provides EU Authorized Representative services for medical devices and IVDs.
Source
“공인 대리인”
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Offers support for ISO 13485 and Quality Management Systems.
Source
“ISO 13485 및 QMS 지원”
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Assists with cosmetic product registration and notification.
Source
“화장품 제품 등록 및 신고 대리인 클레임 대행 GMP 규제”
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Provides pharmaceutical product registration and market approval support.
Source
“제약 제품 등록 시장 승인 보유자 GMP 준수”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking an EU Authorized Representative.
- Medical device manufacturers entering global markets.
- Businesses needing support with ISO 13485 and QMS.
How engagement typically works
- Consultative support for regulatory compliance.
- Acting as a designated representative.
- Assistance with documentation and registration processes.
Typical deliverables
- Authorized Representative services.
- Product registration support.
- QMS documentation and validation.
- Translation and localization.
Good to know
- Best when requiring specialized regulatory support for medical devices, IVDs, cosmetics, or pharmaceuticals.
HQ:
Hyderabad, IN
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Best 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.
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