LFH Regulatory (UKRP Guidance & Support)
LFH Regulatory offers AI-powered medical device regulatory submission services, specializing in FDA and global market compliance. They provide expert guidance and streamlined workflows for submissions like 510(k), De Novo, and PMA.
LFH Regulatory provides comprehensive AI-powered regulatory services designed to streamline medical device submissions for both FDA and global markets. Their platform offers intelligent automation, automated compliance checks, and expert guidance throughout the entire submission process. Services cover a range of regulatory needs, including FDA 510(k) submissions, De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), 513(g) Requests, PMA Supplements, and Humanitarian Device Exemptions (HDE). They also support IDE Submissions. The company emphasizes a complete workflow from device classification to the final submission package, aiming to simplify complex regulatory requirements. For novel, low to moderate-risk devices, LFH Regulatory highlights the mandatory eSTAR use from October 1, 2025. They also offer formal device classification determination and support for 180-day, Real-Time supplements with repeatable templates and checklists. Their platform aims to be a single, intelligent solution for all regulatory needs.
About
**Who they are**
LFH Regulatory (UKRP Guidance & Support) is a UK-based consultancy founded in 2019, specializing in medical device and In Vitro Diagnostic (IVD) regulations. They aim to simplify the compliance process for manufacturers seeking to access the UK market.
**Expertise & scope**
* **UK Responsible Person (UKRP) Services:** Act as the official UKRP, representing non-UK manufacturers to ensure compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002). This includes acting as a point of contact for regulatory authorities.
* **Regulatory Strategy & Market Access:** Provide guidance on navigating UK and global regulatory landscapes, including specific services like Regulatory Strategy / Market Access and Regulatory Intelligence.
* **Quality Management Systems (QMS):** Offer expertise in QMS implementation, including ISO 13485 and MDSAP, as well as QMS Packages.
* **Technical Documentation:** Support includes Technical File preparation, Risk Management, and Biological Evaluation.
* **Clinical & Performance Evaluations:** Assist with Clinical Evaluation and Performance Evaluation processes.
* **MHRA Policy Understanding:** Keep abreast of MHRA policies, including international recognition frameworks for medical devices.
**Reputation / proof points**
* Founded in 2019.
* Team of passionate professionals with expertise across regulatory, quality, and clinical solutions.
* Focus on building strong, long-term client relationships through collaboration and open communication.
LFH Regulatory (UKRP Guidance & Support) is a UK-based consultancy founded in 2019, specializing in medical device and In Vitro Diagnostic (IVD) regulations. They aim to simplify the compliance process for manufacturers seeking to access the UK market.
**Expertise & scope**
* **UK Responsible Person (UKRP) Services:** Act as the official UKRP, representing non-UK manufacturers to ensure compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002). This includes acting as a point of contact for regulatory authorities.
* **Regulatory Strategy & Market Access:** Provide guidance on navigating UK and global regulatory landscapes, including specific services like Regulatory Strategy / Market Access and Regulatory Intelligence.
* **Quality Management Systems (QMS):** Offer expertise in QMS implementation, including ISO 13485 and MDSAP, as well as QMS Packages.
* **Technical Documentation:** Support includes Technical File preparation, Risk Management, and Biological Evaluation.
* **Clinical & Performance Evaluations:** Assist with Clinical Evaluation and Performance Evaluation processes.
* **MHRA Policy Understanding:** Keep abreast of MHRA policies, including international recognition frameworks for medical devices.
**Reputation / proof points**
* Founded in 2019.
* Team of passionate professionals with expertise across regulatory, quality, and clinical solutions.
* Focus on building strong, long-term client relationships through collaboration and open communication.
Additional information
LFH Regulatory emphasizes a tailored approach to compliance, working closely with clients to understand their specific products and business goals. Their UKRP service is designed to alleviate the complexities associated with UK MDR 2002, acting as a crucial liaison with the UK competent authority. They are committed to staying ahead of regulatory changes, including upcoming amendments to UK MDR, ensuring clients remain compliant. For manufacturers based outside the UK, appointing LFH Regulatory as their UKRP is a mandatory step for placing medical devices on the UK market, facilitating broader customer reach and ensuring adherence to safety and performance standards.
Key Highlights
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LFH Regulatory acts as the official UK Responsible Person, representing non-UK manufacturers for UK MDR 2002 compliance.
Source
“We serve as your trusted UK Responsible Person, representing your business in compliance with the UK MDR regulation.”
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Founded in 2019, the consultancy offers specialized services in medical device and IVD regulations.
Source
“Founded in 2019 by Laura Friedl-Hirst, our company has quickly grown into a dynamic team of passionate professionals.”
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Expertise covers Technical File, Risk Management, Biological Evaluation, and Regulatory Strategy / Market Access.
Source
“Technical File Risk Management Biological Evaluation Regulatory Strategy / Market Access”
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Provides support for QMS implementation, including ISO 13485 and MDSAP.
Source
“QMS implementation including ISO 13485 & MDSAP QMS Packages”
Certifications & Trust Signals
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Established in 2019, LFH Regulatory has grown into a dynamic team of professionals.
Source
“Founded in 2019 by Laura Friedl-Hirst, our company has quickly grown into a dynamic team of passionate professionals.”
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The team comprises individuals with unique skill sets offering comprehensive support across regulatory, quality, and clinical solutions.
Source
“Each team member brings a unique skill set and perspective allowing us to provide comprehensive support across regulatory, quality and clinical solutions.”
Buyer Snapshot
Best for
- Manufacturers based outside the UK seeking to place medical devices on the UK market.
- Companies needing a dedicated UK Responsible Person.
- Businesses requiring support with UK MDR 2002 compliance.
How engagement typically works
- Collaborative and communicative.
- Tailored solutions based on client needs.
- Proactive guidance and personalized attention.
Typical deliverables
- UK Responsible Person representation.
- Guidance on UK MDR 2002 compliance.
- Support with Technical Files, Risk Management, and Clinical Evaluations.
- QMS implementation and packages.
- Regulatory Strategy and Market Access advice.
Good to know
- Best when clients require specific expertise in UK medical device regulations.
HQ:
Edinburgh, 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
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
GBP 1,000
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:
Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Device Classes Supported
All classes (implied by UK MDR 2002 coverage)
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
The process involves appointing LFH Regulatory as the UKRP to ensure medical devices meet UK MDR 2002 requirements and act as a point of contact for regulatory authorities.
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