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 specialized provider of governance, risk, and compliance solutions, focusing on UK regulated entities. They offer a seamless and integrated approach to complex regulatory landscapes.

**Expertise & scope**
* Expertise in navigating UK medical device regulations, including Technical File Creation & Registration and UK Responsible Person (UKRP) services.
* Support for AI governance and healthcare AI compliance, including strategy development and ISO 42001 certification.
* Services for building Quality Management Systems (QMS) aligned with ISO 13485.
* Guidance on regulatory roadmaps for market entry, particularly for medical devices and in vitro diagnostics.
* Post-market surveillance support.

**Reputation / proof points**
* Approved as a DSPT Auditor for IT Suppliers to the NHS.

Additional information

8foldGovernance (UKRP) emphasizes a partnership approach, aiming to build lasting relationships and empower businesses for long-term success. They focus on removing the burden of complex compliance, accelerating market entry, and improving patient outcomes. Their services are designed to embed strong governance foundations, regardless of a company's current stage or size. They work with businesses to document evidence in a structured and scalable manner, ensuring a smooth and seamless experience.

Key Highlights

  • Offers UK Responsible Person (UKRP) services for medical devices. Source
    “UK Responsible Person (UKRP)”
  • Provides expert consultancy for medical device regulation, including technical file creation and registration. Source
    “Technical File Creation; Registration”
  • Specializes in AI Governance and healthcare AI compliance, offering strategy and ISO 42001 support. Source
    “Artificial Intelligence Governance; ISO 42001 Certification”
  • Assists in designing and building Quality Management Systems (QMS) aligned with ISO 13485. Source
    “ISO 13485 Design & Build your QMS”
  • Develops tailored Regulatory Roadmaps to navigate medical device compliance. Source
    “Our tailored Regulatory Roadmap is designed to help businesses understand international regulatory requirements”

Certifications & Trust Signals

  • Approved as a DSPT Auditor for IT Suppliers to the NHS. Source
    “8foldGovernance approved as DSPT Auditor for IT Suppliers to the NHS”

Buyer Snapshot

Best for
  • Companies seeking UK Responsible Person services for medical devices.
  • Innovators in AI and healthcare AI needing compliance guidance.
  • Businesses requiring support for ISO 13485 QMS development.
How engagement typically works
  • Partnership-focused, guiding teams for long-term success.
  • Seamless and integrated approach to compliance.
  • Tailored advisory services for complex regulatory environments.
Typical deliverables
  • UK Responsible Person representation.
  • Medical Device Technical File Creation & Registration.
  • ISO 13485 Design & Build QMS.
  • Regulatory Roadmap development.
  • AI Governance Strategy.
Good to know
  • Best when navigating UK medical device and AI regulations.
  • Best when requiring structured QMS development.
HQ: Brighton, 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: 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
Onboarding Steps
The provider guides clients through their compliance journey, helping to embed strong governance foundations and documenting evidence in a structured and scalable way.
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