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 consultancy assisting medical device manufacturers with UK regulatory compliance. They focus on navigating the stringent framework set by the MHRA.
**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 UK MDR compliance and conformity assessment procedures.
* Services extend to pharmaceuticals, life sciences, and consumer goods.
* Offers regulatory support for medical devices and IVDs, including product registration and ISO 13485 & QMS support.
* Provides services for cosmetics, including product registration, notification, and GMP compliance.
* Offers translation and localization services.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Dedicated team of regulatory professionals ensuring accuracy and efficiency.
* Helps businesses stay compliant with evolving regulations.
OMC Medical (UKRP) is a specialized consultancy assisting medical device manufacturers with UK regulatory compliance. They focus on navigating the stringent framework set by the MHRA.
**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 UK MDR compliance and conformity assessment procedures.
* Services extend to pharmaceuticals, life sciences, and consumer goods.
* Offers regulatory support for medical devices and IVDs, including product registration and ISO 13485 & QMS support.
* Provides services for cosmetics, including product registration, notification, and GMP compliance.
* Offers translation and localization services.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Dedicated team of regulatory professionals ensuring accuracy and efficiency.
* Helps businesses stay compliant with evolving regulations.
Additional information
OMC Medical (UKRP) facilitates market access to the UK for medical device manufacturers globally. They simplify the MHRA compliance process, offering comprehensive regulatory solutions. Their services are designed to ensure smooth market entry, ongoing compliance, and a strong competitive position within the UK's healthcare sector. They also provide support for product registration and regulatory approvals across various industries.
Key Highlights
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Specializes in UK Responsible Person (UKRP) services for medical device manufacturers.
Source
“We help manufacturers in the US, China, Japan, South Korea, & more to meet MHRA compliance with ease.”
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Provides expertise in 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 comprehensive regulatory solutions for medical devices and IVDs.
Source
“의료 기기와 IVD의 중요성은 더 빠르고 정확한 진단, 향상된 질병 모니터링, 새로운 치료법 개발 및 환자의 삶의 질 향상을 가능하게 하는 능력에 있습니다”
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Assists with product registration and regulatory approvals for smooth market entry into the UK.
Source
“Ensure Fast & Compliant Market Access to the UK”
Certifications & Trust Signals
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Acts as your UK Responsible Person (UKRP) for smooth compliance.
Source
“Local Representation – Acting as your UK Responsible Person (UKRP) for smooth compliance.”
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Possesses global regulatory expertise in medical devices, IVDs, pharmaceuticals, and cosmetics.
Source
“Global Regulatory Expertise – Extensive experience in medical devices, IVDs, pharmaceuticals, and cosmetics.”
Buyer Snapshot
Best for
- Manufacturers seeking UK Responsible Person services
- Companies needing MHRA registration and UKCA marking support
- Businesses requiring assistance with medical device and IVD compliance in the UK
How engagement typically works
- Provides local representation as UKRP
- Offers end-to-end support for regulatory approvals
- Dedicated professional team for accuracy and efficiency
Typical deliverables
- UK Responsible Person (UKRP) services
- MHRA registration support
- UKCA marking guidance
- Product classification and registration
- Quality assurance and QMS implementation
- Post-market surveillance support
Good to know
- Best when focused on UK market entry and compliance for medical devices and IVDs.
HQ:
Bristol, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Best 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
Yes
UK Entity Country
England
Supports MDR
Yes
Supports IVDR
Yes
Post Market Support
Yes
Vigilance Support
Yes
Onboarding Steps
The process involves verifying technical documentation and ensuring manufacturers follow conformity assessment procedures.
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