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), founded in 2019, is a UK-based consultancy specializing in medical device and In Vitro Diagnostic (IVD) regulations. They offer tailored solutions to simplify the complexities of regulatory compliance.
**Expertise & scope**
* UK Responsible Person (UKRP) services, representing manufacturers for compliance with UK MDR 2002.
* Regulatory Strategy and Market Access guidance.
* Technical File preparation and support.
* Risk Management processes.
* Biological Evaluation.
* Regulatory Intelligence (RI) Services.
* Quality Management System (QMS) implementation, including ISO 13485 and MDSAP.
* Clinical Evaluation and Performance Evaluation support.
* Expertise in navigating UK and European markets, as well as global expansion.
* Monitoring and responding to regulatory changes, including amendments to UK MDR.
**Reputation / proof points**
* Founded in 2019.
* Team of passionate professionals with in-depth knowledge of medical device and IVD regulations.
* Commitment to building strong, long-term client relationships through collaboration and open communication.
* Focus on proactive guidance, transparent communication, and personalized attention.
LFH Regulatory (UKRP Guidance & Support), founded in 2019, is a UK-based consultancy specializing in medical device and In Vitro Diagnostic (IVD) regulations. They offer tailored solutions to simplify the complexities of regulatory compliance.
**Expertise & scope**
* UK Responsible Person (UKRP) services, representing manufacturers for compliance with UK MDR 2002.
* Regulatory Strategy and Market Access guidance.
* Technical File preparation and support.
* Risk Management processes.
* Biological Evaluation.
* Regulatory Intelligence (RI) Services.
* Quality Management System (QMS) implementation, including ISO 13485 and MDSAP.
* Clinical Evaluation and Performance Evaluation support.
* Expertise in navigating UK and European markets, as well as global expansion.
* Monitoring and responding to regulatory changes, including amendments to UK MDR.
**Reputation / proof points**
* Founded in 2019.
* Team of passionate professionals with in-depth knowledge of medical device and IVD regulations.
* Commitment to building strong, long-term client relationships through collaboration and open communication.
* Focus on proactive guidance, transparent communication, and personalized attention.
Additional information
LFH Regulatory acts as the appointed UK Responsible Person, serving as the primary point of contact for UK regulatory authorities on behalf of manufacturers based outside the UK. This role is crucial for ensuring medical devices meet the requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002) and facilitating market access. They are committed to staying informed about upcoming regulatory changes, such as amendments to the UK MDR, and are prepared to adapt their services accordingly. Their approach aims to streamline the compliance process, making it less burdensome for clients seeking to place their devices on the UK market.
Key Highlights
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LFH Regulatory offers dedicated UK Responsible Person (UKRP) services to ensure compliance with UK MDR 2002 for manufacturers outside the UK.
Source
“We serve as your trusted UK Responsible Person, representing your business in compliance with the UK MDR regulation.”
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The company provides comprehensive support for medical device regulatory submissions, including 510(k), De Novo, and PMA, alongside FDA and global market compliance.
Source
“LFH Regulatory offers AI-powered medical device regulatory submission services, specializing in FDA and global market compliance.”
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Expertise extends to Quality Management Systems (QMS) implementation, including ISO 13485 and MDSAP, and QMS packages.
Source
“QMS implementation including ISO 13485 & MDSAP QMS Packages”
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They offer support for Clinical and Performance Evaluations, vital steps in validating medical device safety and efficacy.
Source
“Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.”
Certifications & Trust Signals
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Founded in 2019, LFH Regulatory has grown into a dynamic team of passionate 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 includes experienced consultants with in-depth knowledge of Medical Device and In Vitro Diagnostic Regulations.
Source
“Our experienced consultants have an in-depth knowledge of the intricacies of Medical Device and In Vitro Diagnostic Regulations.”
Buyer Snapshot
Best for
- Manufacturers outside the UK seeking UK market access.
- Companies needing a dedicated UK Responsible Person.
- Businesses requiring support with UK MDR 2002 compliance.
How engagement typically works
- Collaborative and communicative.
- Proactive guidance.
- Personalized attention.
Typical deliverables
- UK Responsible Person representation.
- Regulatory strategy and market access plans.
- Technical file support.
- QMS implementation guidance.
- Clinical and performance evaluation support.
Good to know
- Best when requiring specific UK regulatory representation and compliance support.
HQ:
Edinburgh, 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
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
Class I, Class III Implants, SaMD (Software as a Medical Device)
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
Appointing LFH Regulatory as UKRP ensures compliance with UK regulations and facilitates market access.
