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 service provider focused on regulatory compliance for medical devices, IVDs, cosmetics, and pharmaceuticals. They aim to assist clients in navigating complex global market entry requirements.
**Expertise & scope**
* Assistance with product registration for medical devices, IVDs, cosmetics, and pharmaceuticals.
* Provision of Authorized Representative services for medical devices and cosmetics.
* Support for ISO 13485 and Quality Management Systems (QMS).
* Services related to GMP compliance for cosmetics and pharmaceuticals.
* Translation and localization services.
* Supplier audits and internal audits.
* Process and procedure validation.
* Gap analysis and document compilation.
**Reputation / proof points**
* ISO 13485:2016 certified.
* ISO 17100:2015 certified.
OMC Medical (EUAR) is a service provider focused on regulatory compliance for medical devices, IVDs, cosmetics, and pharmaceuticals. They aim to assist clients in navigating complex global market entry requirements.
**Expertise & scope**
* Assistance with product registration for medical devices, IVDs, cosmetics, and pharmaceuticals.
* Provision of Authorized Representative services for medical devices and cosmetics.
* Support for ISO 13485 and Quality Management Systems (QMS).
* Services related to GMP compliance for cosmetics and pharmaceuticals.
* Translation and localization services.
* Supplier audits and internal audits.
* Process and procedure validation.
* Gap analysis and document compilation.
**Reputation / proof points**
* ISO 13485:2016 certified.
* ISO 17100:2015 certified.
Additional information
OMC Medical (EUAR) supports clients in achieving compliance with regulations such as those set by the US FDA and European EU cosmetics regulations. They emphasize the importance of meeting legal requirements, safety standards, and ingredient disclosure. For medical devices, they highlight the need to fulfill national regulatory requirements for market release, positioning themselves as a partner to facilitate global market entry.
Key Highlights
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Provides Authorized Representative services for medical devices and IVDs.
Source
“공인 대리인”
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Offers ISO 13485 and QMS support for medical device manufacturers.
Source
“ISO 13485 및 QMS 지원”
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Provides product registration and representation for cosmetics.
Source
“제품 등록 및 신고 대리인”
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Certified to ISO 13485:2016 and ISO 17100:2015 standards.
Source
“ISO 13485:2016 인증; ISO 17100:2015 인증”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking EU Authorized Representative services.
- Manufacturers of medical devices and IVDs requiring product registration.
- Cosmetic and pharmaceutical companies needing regulatory support.
How engagement typically works
- Project-based support for registration and compliance.
- Ongoing retainer for representation and QMS support.
Typical deliverables
- Product registration filings.
- Authorized Representative appointments.
- QMS documentation and validation support.
- Translation and localization of product information.
Good to know
- Best when clients require assistance with market access in the EU and UK.
HQ:
Hyderabad, IN
Languages:
English
Timezones:
Europe/London
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
Implied through Authorized Representative services for medical devices.
Supports IVDR
Implied through services for IVDs.
Post Market Support
Mentioned in the context of medical device regulations.
Vigilance Contact Support
Implied through Authorized Representative role.
