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 focus on simplifying complex regulatory processes for clients seeking market access.
**Expertise & scope**
* **UK Responsible Person (UKRP) Services:** Act as the official UKRP, representing manufacturers based outside the UK to ensure compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002). This includes acting as a point of contact for regulatory authorities and ensuring devices meet UK competent authority requirements.
* **Regulatory Strategy & Market Access:** Provide guidance on navigating UK and global markets, including regulatory intelligence and strategy development.
* **Quality Management Systems (QMS):** Offer expertise in QMS implementation, including ISO 13485 and MDSAP, as well as providing QMS packages.
* **Clinical & Performance Evaluations:** Support with clinical and performance evaluations to validate device safety and efficacy.
* **Technical Documentation:** Assist with the creation and management of Technical Files.
* **Risk Management:** Provide services related to risk management for medical devices.
* **Biological Evaluation:** Offer support for biological evaluation requirements.
* **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.
* Commitment to 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 focus on simplifying complex regulatory processes for clients seeking market access.
**Expertise & scope**
* **UK Responsible Person (UKRP) Services:** Act as the official UKRP, representing manufacturers based outside the UK to ensure compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002). This includes acting as a point of contact for regulatory authorities and ensuring devices meet UK competent authority requirements.
* **Regulatory Strategy & Market Access:** Provide guidance on navigating UK and global markets, including regulatory intelligence and strategy development.
* **Quality Management Systems (QMS):** Offer expertise in QMS implementation, including ISO 13485 and MDSAP, as well as providing QMS packages.
* **Clinical & Performance Evaluations:** Support with clinical and performance evaluations to validate device safety and efficacy.
* **Technical Documentation:** Assist with the creation and management of Technical Files.
* **Risk Management:** Provide services related to risk management for medical devices.
* **Biological Evaluation:** Offer support for biological evaluation requirements.
* **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.
* Commitment to building strong, long-term client relationships through collaboration and open communication.
Additional information
LFH Regulatory emphasizes a tailored approach, working closely with clients to understand their specific business and product challenges. Their services are designed to streamline compliance, particularly for manufacturers outside the UK aiming to place medical devices on the UK market. They are committed to staying ahead of regulatory changes, such as upcoming amendments to the UK MDR, ensuring clients remain compliant. The company highlights its proactive guidance, transparent communication, and personalized attention throughout the regulatory process. They also offer a FREE UKRP Checklist for potential clients.
Key Highlights
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Specializes in UK Responsible Person (UKRP) services for market access under UK MDR 2002.
Source
“We serve as your trusted UK Responsible Person, representing your business in compliance with the UK MDR regulation.”
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Offers comprehensive regulatory support including Technical File, Risk Management, and Regulatory Strategy.
Source
“Technical File; Risk Management; Biological Evaluation; Regulatory Strategy / Market Access; Regulatory Intelligence (RI) Services”
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Provides Quality Management System (QMS) implementation support, including ISO 13485 and MDSAP.
Source
“QMS implementation including ISO 13485 & MDSAP; QMS Packages”
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Founded in 2019, with a team experienced in diverse 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.”
Certifications & Trust Signals
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Established in 2019, indicating several years of operational experience.
Source
“Founded in 2019 by Laura Friedl-Hirst, our company has quickly grown into a dynamic team of passionate professionals.”
Buyer Snapshot
Best for
- Manufacturers outside the UK seeking to place medical devices on the UK market.
- Companies needing to appoint a UK Responsible Person.
- Businesses requiring assistance with UK MDR 2002 compliance.
How engagement typically works
- Collaborative and communicative.
- Proactive guidance and personalized attention.
- Tailored solutions based on specific client needs.
Typical deliverables
- Designated UK Responsible Person services.
- Regulatory strategy and market access support.
- Technical File preparation assistance.
- QMS implementation guidance.
- Clinical and performance evaluation support.
Good to know
- Best when clients require specialized UK regulatory expertise.
- Most effective for medical device and IVD manufacturers.
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 scope of UK MDR 2002 and specific mentions of Class I SaMD to Class III Implants)
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
The company offers a FREE UKRP Checklist, suggesting an initial assessment phase. Detailed onboarding steps are not explicitly listed but imply a process of consultation and representation.
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