8foldGovernance (UKRP)
8foldGovernance
8foldGovernance offers expert governance, risk, and compliance solutions for UK regulated entities. They provide tailored advisory services to navigate complex regulatory landscapes.
8foldGovernance is a specialist consultancy focused on providing comprehensive governance, risk, and compliance (GRC) services. They cater to regulated entities within the UK, offering tailored solutions to meet specific industry and regulatory requirements. Their expertise spans across various aspects of GRC, ensuring that clients can operate effectively and compliantly within the UK's stringent regulatory framework. With a commitment to delivering practical and actionable advice, 8foldGovernance helps organizations to identify and mitigate risks, strengthen their internal controls, and enhance their overall governance structures. They work closely with clients to understand their unique challenges and develop customized strategies that align with business objectives and regulatory obligations. Their services are designed to build trust and ensure long-term sustainability for their clients in the UK market.
About
**Who they are**
8foldGovernance (UKRP) is a full-service provider of governance, risk, and compliance solutions for UK regulated entities, with an in-house team of regulatory and compliance experts.
**Expertise & scope**
* Expertise in navigating complex regulatory landscapes for UK regulated entities.
* Specializes in AI Governance, Medical Devices, and International Standards.
* Services include Regulatory Roadmap development, ISO 13485 Design & Build of QMS, Quality Management as a Service, Technical File Creation & Registration, UK Responsible Person services, and Post Market Surveillance.
* Offers support for ISO 13485, ISO 42001, ISO 9001, and ISO 27001 certifications.
* Provides guidance for Software as a Medical Device, AI as a Medical Device, and In Vitro Diagnostic (IVD) solutions.
* Develops Clinical or Performance Evaluations to support device validation.
**Reputation / proof points**
* Works with companies at any stage or size to embed strong governance foundations.
* Aims to remove the burden of complex compliance and accelerate the journey for businesses, improving patient outcomes and strengthening the healthcare ecosystem.
8foldGovernance (UKRP) is a full-service provider of governance, risk, and compliance solutions for UK regulated entities, with an in-house team of regulatory and compliance experts.
**Expertise & scope**
* Expertise in navigating complex regulatory landscapes for UK regulated entities.
* Specializes in AI Governance, Medical Devices, and International Standards.
* Services include Regulatory Roadmap development, ISO 13485 Design & Build of QMS, Quality Management as a Service, Technical File Creation & Registration, UK Responsible Person services, and Post Market Surveillance.
* Offers support for ISO 13485, ISO 42001, ISO 9001, and ISO 27001 certifications.
* Provides guidance for Software as a Medical Device, AI as a Medical Device, and In Vitro Diagnostic (IVD) solutions.
* Develops Clinical or Performance Evaluations to support device validation.
**Reputation / proof points**
* Works with companies at any stage or size to embed strong governance foundations.
* Aims to remove the burden of complex compliance and accelerate the journey for businesses, improving patient outcomes and strengthening the healthcare ecosystem.
Additional information
8foldGovernance (UKRP) focuses on building lasting partnerships to guide teams and empower businesses for long-term success. They offer a seamless and integrated approach, acting as a guide through uncharted waters in AI and medical device regulation. Their services are designed to accelerate your journey, benefiting your business, improving patient outcomes, and strengthening the healthcare ecosystem. They work with companies of all sizes, helping them find a route from their current position to their desired regulatory standing, embracing good governance without distraction.
Key Highlights
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Offers comprehensive services for Medical Devices, including Regulatory Roadmap, ISO 13485 QMS Design & Build, Technical File Creation, UK Responsible Person, and Post Market Surveillance.
Source
“Medical Devices Regulatory Roadmap ISO 13485 Design & Build your QMS Quality Management as a Service Technical File Creation & Registration UK Responsible Person Post Market Surveillance”
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Provides expert consultancy for medical device regulation, assisting with market entry and bringing innovations to market swiftly and confidently.
Source
“Expert Medical Device Consultancy for groundbreaking innovation. Whether you’re developing Software as a Medical Device, AI as a Medical Device or In Vitro Diagnostic (IVD) solutions, we’re here to help you bring your innovations to market swiftly and confidently.”
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Specializes in Artificial Intelligence Governance, ensuring AI systems meet current and future expectations with a human-centered approach.
Source
“Artificial Intelligence Governance, Healthcare AI Compliance From strategy to implementation, we provide holistic support to ensure your AI systems meet both today’s requirements and tomorrow’s expectations, with a human centered approach.”
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Offers support for various international standards, including ISO 13485, ISO 42001, ISO 9001, and ISO 27001 certifications.
Source
“International Standards ISO 13485 Certification ISO 42001 Certification ISO 9001 Certification ISO 27001 Certification”
Certifications & Trust Signals
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Full-service provider with an in-house team of regulatory and compliance experts.
Source
“As the only full-service provider with an in-house team of regulatory and compliance experts, we offer a seamless and integrated approach.”
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Works with companies at any stage or size to embed strong governance foundations.
Source
“With deep domain expertise built from working in health and care systems globally, we work with companies at any stage or size to embed strong governance foundations.”
Buyer Snapshot
Best for
- Companies seeking end-to-end compliance solutions for healthcare innovators.
- Businesses navigating complex regulatory landscapes in the UK.
- Organizations requiring support for AI governance and medical device regulation.
How engagement typically works
- Partnership-focused approach.
- Tailored advisory services.
- Seamless and integrated support.
Typical deliverables
- Regulatory Roadmaps.
- ISO 13485 QMS Design & Build.
- Technical File Creation & Registration.
- UK Responsible Person services.
- Post Market Surveillance plans.
- ISO certification support.
Good to know
- Best when seeking expert guidance to navigate complex regulatory environments.
HQ:
Brighton, 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 1,500
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
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III
Supports GB:
Yes
Supports NI:
Yes
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Device Classes Supported
All
Supports MDR
true
Supports IVDR
true
Supports GB
true
Vigilance Support
true
Post Market Support
true
UK Entity Country
England
