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 regulatory support provider specializing in services for medical devices and IVDs, with a focus on UK market access. They assist manufacturers globally in navigating complex regulatory landscapes.
**Expertise & scope**
* Expertise in UK Responsible Person (UKRP) services, UKCA marking, and MHRA registration.
* Support for product classification, local representation, quality assurance, clinical evaluation, and post-market surveillance.
* Assistance with product registration, supplier audits, QMS implementation, process validation, and regulatory documentation.
* Services extend to cosmetics and pharmaceuticals, including product registration, agent services, and GMP compliance.
* Translation and localization services are also offered.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Provides end-to-end support for product registration and regulatory approvals.
* Offers dedicated support from a team of regulatory professionals.
OMC Medical (UKRP) is a regulatory support provider specializing in services for medical devices and IVDs, with a focus on UK market access. They assist manufacturers globally in navigating complex regulatory landscapes.
**Expertise & scope**
* Expertise in UK Responsible Person (UKRP) services, UKCA marking, and MHRA registration.
* Support for product classification, local representation, quality assurance, clinical evaluation, and post-market surveillance.
* Assistance with product registration, supplier audits, QMS implementation, process validation, and regulatory documentation.
* Services extend to cosmetics and pharmaceuticals, including product registration, agent services, and GMP compliance.
* Translation and localization services are also offered.
**Reputation / proof points**
* Acts as a UK Responsible Person (UKRP) for smooth compliance.
* Provides end-to-end support for product registration and regulatory approvals.
* Offers dedicated support from a team of regulatory professionals.
Additional information
OMC Medical (UKRP) facilitates market entry into the UK for medical device and IVD manufacturers. They emphasize simplifying the MHRA compliance process through services like UKCA marking and acting as the UK Responsible Person. Their support covers the entire product lifecycle, from initial classification and registration to ongoing post-market surveillance, ensuring manufacturers can maintain compliance within the UK's evolving healthcare sector. They also offer tailored solutions across pharmaceuticals, life sciences, and consumer goods.
Key Highlights
-
Specializes in UK Responsible Person (UKRP) services, UKCA marking, and MHRA registration for medical devices.
Source
“With expertise in UKCA marking, MHRA registration, and UKRP (UK Responsible Person) services, we ensure a seamless approval process for your products.”
-
Assists manufacturers globally in navigating the UK’s stringent regulatory framework for medical devices and IVDs.
Source
“We help manufacturers in the US, China, Japan, South Korea, & more to meet MHRA compliance with ease.”
-
Provides comprehensive regulatory solutions including product classification, local representation, 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.”
-
Offers services for product registration, supplier audits, QMS implementation, and regulatory documentation.
Source
“OMC Medical simplifies this process by providing expert assistance in UKCA marking, MHRA registration, UK Responsible Person (UKRP) services, supplier audits, QMS implementation, process validation, and regulatory documentation.”
Certifications & Trust Signals
-
Acts as a UK Responsible Person (UKRP) for smooth compliance.
Source
“Local Representation – Acting as your UK Responsible Person (UKRP) for smooth compliance.”
-
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 market access for medical devices and IVDs.
- Companies needing a UK Responsible Person (UKRP).
- Businesses requiring assistance with MHRA registration and UKCA marking.
How engagement typically works
- Provides local representation as UKRP.
- Offers end-to-end support for regulatory approvals.
- Dedicated team of regulatory professionals.
Typical deliverables
- UK Responsible Person services.
- MHRA registration support.
- UKCA marking assistance.
- Product classification and registration.
- Post-market surveillance support.
Good to know
- Best when requiring specialized UK regulatory expertise for medical devices and IVDs.
HQ:
Bristol, UK
Languages:
English
Timezones:
Europe/London
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
Implied through medical device services, but not explicitly stated as 'MDR support'.
Supports IVDR
Implied through IVD services, but not explicitly stated as 'IVDR support'.
Post Market Support
Yes
