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 and IVD manufacturers in navigating the UK's regulatory framework. They focus on providing expert support for market access and ongoing compliance.
**Expertise & scope**
* Expertise in UKCA marking, MHRA registration, and UK Responsible Person (UKRP) services.
* Assistance with product classification, local representation, quality assurance, clinical evaluation, and post-market surveillance.
* Support for manufacturers globally, including those in the US, China, Japan, and South Korea.
* Services extend to pharmaceuticals, life sciences, and consumer goods.
* Verification of technical documentation and compliance with UK MDR.
* Ensuring manufacturers follow conformity assessment procedures.
* Specialization in UK Responsible Person services, product registration, and compliance for medical devices and IVDs.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Provides end-to-end support for product registration and regulatory approvals.
* Dedicated team of regulatory professionals ensuring accuracy and efficiency.
OMC Medical (UKRP) is a specialized consultancy assisting medical device and IVD manufacturers in navigating the UK's regulatory framework. They focus on providing expert support for market access and ongoing compliance.
**Expertise & scope**
* Expertise in UKCA marking, MHRA registration, and UK Responsible Person (UKRP) services.
* Assistance with product classification, local representation, quality assurance, clinical evaluation, and post-market surveillance.
* Support for manufacturers globally, including those in the US, China, Japan, and South Korea.
* Services extend to pharmaceuticals, life sciences, and consumer goods.
* Verification of technical documentation and compliance with UK MDR.
* Ensuring manufacturers follow conformity assessment procedures.
* Specialization in UK Responsible Person services, product registration, and compliance for medical devices and IVDs.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Provides end-to-end support for product registration and regulatory approvals.
* Dedicated team of regulatory professionals ensuring accuracy and efficiency.
Additional information
OMC Medical (UKRP) simplifies the process of entering the UK market for medical devices and IVDs, which are strictly regulated by the MHRA. They offer comprehensive regulatory solutions, including assistance with UKCA marking, MHRA registration, and acting as the UK Responsible Person. Their services are designed to ensure smooth market entry, maintain ongoing compliance, and establish a strong competitive position within the UK's evolving healthcare sector. They also provide support for supplier audits, QMS implementation, process validation, and regulatory documentation.
Key Highlights
-
Specializes in UK Responsible Person (UKRP) services for medical devices.
Source
“We help manufacturers in the US, China, Japan, South Korea, & more to meet MHRA compliance with ease.”
-
Provides expert assistance 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.”
-
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”
-
Assists manufacturers globally in navigating complex regulatory landscapes.
Source
“At OMC Medical, we specialize in assisting medical device manufacturers in navigating the UK’s stringent regulatory framework.”
Certifications & Trust Signals
-
Acts as your UK Responsible Person (UKRP) for smooth compliance.
Source
“Local Representation – Acting as your UK Responsible Person (UKRP) for smooth compliance.”
-
Dedicated team of regulatory professionals ensuring accuracy and efficiency.
Source
“Dedicated Support – A team of regulatory professionals ensuring accuracy and efficiency.”
Buyer Snapshot
Best for
- Manufacturers seeking UK market access for medical devices and IVDs
- Companies needing a UK Responsible Person (UKRP)
- Businesses requiring assistance with MHRA compliance and UKCA marking
How engagement typically works
- Consultative approach to regulatory challenges
- Dedicated professional support for compliance
- Partnership for seamless market entry
Typical deliverables
- UK Responsible Person services
- MHRA registration support
- UKCA marking guidance
- Product classification and registration
- Quality Management System (QMS) implementation support
- Post-market surveillance assistance
Good to know
- Best when requiring specialized knowledge of UK medical device regulations.
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.
⚡ Instant booking available
Appoint a UK Responsible Person for UKCA Medical Devices
Compare OMC Medical (UKRP) and other vetted providers — instant pricing, no RFQ needed.
