IMed Consultancy (UKRP)
IMed Consultancy Ltd
IMed Consultancy offers expert UKRP services for medical devices and IVDs, ensuring compliance with UK regulations post-Brexit. They provide direct access to UK-based QA/RA experts for market entry.
IMed Consultancy specializes in UKRP (UK Responsible Person) services, guiding medical device and IVD manufacturers through the complexities of the UK market. Following Brexit, European regulations no longer apply, and IMed Consultancy ensures your products meet the specific UK requirements, including demonstrating compliance with UK MDR 2002 and managing MHRA registrations. Benefit from direct access to a dedicated team of UK-based QA/RA experts who provide strategic guidance and support for your market entry. IMed Consultancy acts on your behalf, offering a qualified and experienced UKRP to navigate regulatory changes and protect your market position. They are equipped to support global manufacturers with their regulatory and compliance needs within the UK.
About
**Who they are**
IMed Consultancy (UKRP) is a UK-based consultancy specializing in regulatory affairs for medical devices and in-vitro diagnostics. They offer direct access to UK-based QA/RA experts to ensure compliance with UK regulations.
**Expertise & scope**
* Expertise in UK Responsible Person (UKRP) services for medical devices and IVDs.
* Assistance with global registration for medical devices and IVDs.
* Support for implementing and maintaining Quality Management Systems (QMS).
* Guidance on Software as a Medical Device (SaMD) and Person Responsible for Regulatory Compliance (PRRC).
* Services extend to Companion Diagnostics and training programs.
* Advising on market entry strategies for the UK, Europe, and other international markets.
**Reputation / proof points**
* Extensive experience in the IVD industry, with over 20 years of knowledge.
* Support for a varied client base, from SMEs to established market leaders.
IMed Consultancy (UKRP) is a UK-based consultancy specializing in regulatory affairs for medical devices and in-vitro diagnostics. They offer direct access to UK-based QA/RA experts to ensure compliance with UK regulations.
**Expertise & scope**
* Expertise in UK Responsible Person (UKRP) services for medical devices and IVDs.
* Assistance with global registration for medical devices and IVDs.
* Support for implementing and maintaining Quality Management Systems (QMS).
* Guidance on Software as a Medical Device (SaMD) and Person Responsible for Regulatory Compliance (PRRC).
* Services extend to Companion Diagnostics and training programs.
* Advising on market entry strategies for the UK, Europe, and other international markets.
**Reputation / proof points**
* Extensive experience in the IVD industry, with over 20 years of knowledge.
* Support for a varied client base, from SMEs to established market leaders.
Additional information
IMed Consultancy provides resources to help businesses stay informed about the IVD and Medical Device industry. These include white papers and guides on topics such as market entry strategies for the UK, US, and Europe, as well as compliance with post-market surveillance (PMS). They aim to equip clients with the necessary background information for regulatory compliance and market access.
Key Highlights
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Offers direct access to UK-based QA/RA experts for regulatory compliance.
Source
“They provide direct access to UK-based QA/RA experts for market entry.”
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Specializes in UK Responsible Person (UKRP) services for medical devices and IVDs.
Source
“IMed Consultancy offers expert UKRP services for medical devices and IVDs, ensuring compliance with UK regulations post-Brexit.”
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Provides expertise in global registration for medical devices and IVDs.
Source
“Global Registration”
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Offers support for Quality Management Systems (QMS) implementation and maintenance.
Source
“Need help with implementing or maintaining a Quality Management System?”
Certifications & Trust Signals
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Established consultancy with extensive experience in the IVD industry.
Source
“IMed has over 20 years’ experience in the IVD industry and a comprehensive knowledge of global quality and regulatory requirements in this area.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking UKRP services.
- Companies looking to navigate post-Brexit UK regulations.
- Businesses expanding into international markets.
How engagement typically works
- Direct consultation with QA/RA experts.
- Tailored training programs.
- Provision of informational resources.
Typical deliverables
- UK Responsible Person appointment and support.
- Regulatory strategy and market access guidance.
- Quality Management System implementation and maintenance.
- Training materials and sessions.
Good to know
- Best when requiring specialized UK regulatory expertise for medical devices and IVDs.
HQ:
Banbury, 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:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
GBP 1,400
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
Supports NI:
Yes
Device Classes Supported:
IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Supports IVDR
Yes (implied by medical device and IVD services)
Supports GB
Yes
UK Entity Country
England
Device Classes Supported
Class I, IIa, IIb, III (implied by medical device and IVD services)
Supports MDR
Yes (implied by medical device and IVD services)
Vigilance Support
Yes (implied by post-market surveillance resources)
Post Market Support
Yes (implied by post-market surveillance resources)
Onboarding Steps
Contact for consultation and tailored solutions.
