OMC Medical (UKRP)
OMC Medical
OMC Medical offers expert regulatory support for medical devices and IVDs, specializing in UK Responsible Person services, product registration, and compliance. They assist manufacturers globally in navigating complex regulatory landscapes.
OMC Medical is a UK-based provider of comprehensive regulatory support for medical devices and IVDs, with a global reach. They specialize in assisting manufacturers, particularly those based outside the UK, in meeting the requirements for placing devices on the Great Britain market, including the appointment of a UK Responsible Person. Their services encompass product registration, classification, technical documentation, quality assurance, and post-market surveillance. OMC Medical also provides guidance on cosmetic and food supplement regulations, as well as translation services to ensure compliance across different regions. With a focus on navigating the evolving regulatory environment, including MHRA guidance for software medical devices and apps, OMC Medical acts as a trusted partner to help clients successfully launch and maintain their products in the global market. They offer free consultations to address specific queries and guide clients through the regulatory process.
About
**Who they are**
OMC Medical (UKRP) is a specialized provider assisting medical device manufacturers in navigating the UK's regulatory framework, focusing on MHRA compliance and UK Responsible Person services.
**Expertise & scope**
* Expertise in UKCA marking, MHRA registration, and UK Responsible Person (UKRP) services.
* Support for product classification, local representation, quality assurance, clinical evaluation, and post-market surveillance.
* Assistance with conformity assessment procedures and verification of technical documentation against UK MDR.
* Services extend to pharmaceuticals, life sciences, and consumer goods.
* Offers regulatory support for medical devices and IVDs, including product registration, Authorized Representative services, and ISO 13485 & QMS support.
* Provides services for cosmetics, including product registration and notification, representation, claims support, and GMP regulations.
* Offers services for pharmaceuticals, including product registration, market authorization holder services, and GMP compliance.
* Translation and localization services are also available.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Dedicated team of regulatory professionals ensuring accuracy and efficiency.
* Focuses on risk mitigation by helping businesses stay compliant with evolving regulations.
OMC Medical (UKRP) is a specialized provider assisting medical device manufacturers in navigating the UK's regulatory framework, focusing on MHRA compliance and UK Responsible Person services.
**Expertise & scope**
* Expertise in UKCA marking, MHRA registration, and UK Responsible Person (UKRP) services.
* Support for product classification, local representation, quality assurance, clinical evaluation, and post-market surveillance.
* Assistance with conformity assessment procedures and verification of technical documentation against UK MDR.
* Services extend to pharmaceuticals, life sciences, and consumer goods.
* Offers regulatory support for medical devices and IVDs, including product registration, Authorized Representative services, and ISO 13485 & QMS support.
* Provides services for cosmetics, including product registration and notification, representation, claims support, and GMP regulations.
* Offers services for pharmaceuticals, including product registration, market authorization holder services, and GMP compliance.
* Translation and localization services are also available.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Dedicated team of regulatory professionals ensuring accuracy and efficiency.
* Focuses on risk mitigation by helping businesses stay compliant with evolving regulations.
Additional information
OMC Medical (UKRP) facilitates market access to the UK for manufacturers globally, including those from the US, China, and Japan. They emphasize a streamlined approval process and ongoing compliance within the UK's evolving healthcare sector. Their services are designed to ensure manufacturers meet stringent MHRA requirements, simplifying the complexities of UKCA marking and product registration. They offer tailored solutions across various industries, aiming to establish a strong competitive position for their clients in the UK market.
Key Highlights
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Specializes in UK Responsible Person (UKRP) services for medical device manufacturers.
Source
“Looking for a UK Responsible Person? We help manufacturers in the US, China, Japan, South Korea, & more to meet MHRA compliance with ease.”
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Provides comprehensive regulatory solutions for UKCA marking and MHRA registration.
Source
“With expertise in UKCA marking, MHRA registration, and UKRP (UK Responsible Person) services, we ensure a seamless approval process for your products.”
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Offers support across diverse industries including medical devices, IVDs, pharmaceuticals, and cosmetics.
Source
“의료 기기 및 IVD 제품 등록 공인 대리인 ISO 13485 및 QMS 지원”
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Assists with product classification, local representation, quality assurance, and post-market surveillance.
Source
“Whether you need support with product classification, local representation, quality assurance, clinical evaluation, or post-market surveillance, our dedicated team in the UK provides comprehensive regulatory solutions.”
Certifications & Trust Signals
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Acts as a local representative for manufacturers to ensure smooth compliance with UK regulations.
Source
“Local Representation – Acting as your UK Responsible Person (UKRP) for smooth compliance.”
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Dedicated team of regulatory professionals focused on accuracy and efficiency.
Source
“Dedicated Support – A team of regulatory professionals ensuring accuracy and efficiency.”
Buyer Snapshot
Best for
- Manufacturers seeking UK Responsible Person services
- Companies needing assistance with MHRA compliance
- Businesses entering the UK medical device market
How engagement typically works
- Provides local representation
- Offers end-to-end support for regulatory approvals
- Dedicated professional team
Typical deliverables
- UK Responsible Person (UKRP) services
- MHRA registration support
- UKCA marking assistance
- Product classification guidance
- Quality assurance support
- Post-market surveillance
Good to know
- Best when targeting market entry or ongoing compliance within the UK regulatory framework.
HQ:
Bristol, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Find UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
GBP 3,500
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
MHRA Support:
Yes
Vigilance Support:
Yes
Device Classes Supported:
IVD
Supports NI:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Additional uk_rp Details
Supports GB
England, Scotland, Wales
UK Entity Country
England
Supports MDR
true
Supports IVDR
true
Post Market Support
Yes
Vigilance Support
true
Onboarding Steps
The process involves verifying technical documentation and ensuring manufacturers follow conformity assessment procedures.
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