LFH Regulatory Limited
LFH Regulatory Limited is a UK-based specialist regulatory consultancy serving medical device, IVD, SaMD, and MedTech startup manufacturers with EU MDR, UK MDR, IVDR, FDA, ISO 13485, and QMS compliance services. Founded in 2019 in Leeds and delivered by 11 named specialists on a quote-based engagement model.
- Company typePrivate
- Founded2019
- HeadquartersLeeds (Yeadon), United Kingdom
- Headcount1–10
- GTM typeB2B
- OfferingServices
What LFH Regulatory Limited does
LFH Regulatory Limited is a UK-based specialist regulatory, quality and clinical consultancy founded in 2019 by Laura Friedl-Hirst, operating exclusively in the medical device and in vitro diagnostics (IVD) sector. The firm's service portfolio covers the full regulatory lifecycle: technical file compilation, risk management (ISO 14971), biological evaluation (ISO 10993), clinical evaluation under EU MDR Article 61, performance evaluation under IVDR, quality management system implementation (ISO 13485, MDSAP), UK Responsible Person and EU Authorised Representative services, regulatory intelligence, global registrations, NHS DTAC / DCB0129 compliance, ISO 27001 information security, and structured training. It serves four primary verticals — medical device manufacturers, IVD manufacturers, software as a medical device (SaMD) companies (including AI-enabled medical technologies), and early-stage healthcare MedTech startups — across clients ranging from pre-revenue startups to global enterprises such as ILS Group.
The operating model is professional services only; there is no proprietary software, SaaS platform, or technology IP. Engagements are scoped and delivered by 11 named specialists listed on the company website (Laura Friedl-Hirst as Managing Director; Zara Malik as Head of Regulatory Affairs; Dr Yupei Xiao as Senior Clinical Consultant; Alexander Madell as QA/RA Consultant; six additional consultants; and Morgan Malone as Business Development Manager). Pricing is quote-based with no published tiers, and engagements are initiated through a free consultation via the website contact form, direct phone, or industry event introductions. The go-to-market is sales-led, supported by content marketing — an extensive educational blog on EU MDR, IVDR, SaMD, AI Act, FDA and NHS topics; an active LinkedIn presence; a YouTube channel (@lfhregulatory); a newsletter; SEO-optimised organic search; and physical presence at MEDICA and Arab Health conferences.
LFH Regulatory is a private limited company incorporated in England and Wales (registered number 11634249), headquartered at 25-29 Sandy Way, Yeadon, Leeds, LS19 7EW. It is founder-led with no disclosed institutional investors, parent entity, subsidiaries, or M&A activity, making it entirely bootstrapped. No revenue, ARR, headcount revenue-per-employee, or funding figures are disclosed in the public record. The company has won two regional awards in 2024 (Eaton Smith Solicitors Business of the Month; Gender Inclusive Employer) and served as a judging partner at the 2025 Health Tech World Awards.
LFH Regulatory Limited firmographics
Firmographics- Name
- LFH Regulatory Limited
- Legal name
- LFH Regulatory Limited
- Website
- https://lfhregulatory.co.uk
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- LFH Regulatory Limited is a UK-based specialist regulatory consultancy serving medical device, IVD, SaMD, and MedTech startup manufacturers with EU MDR, UK MDR, IVDR, FDA, ISO 13485, and QMS compliance services. Founded in 2019 in Leeds and delivered by 11 named specialists on a quote-based engagement model.
- Ownership category
- akta.pro rank
LFH Regulatory Limited industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industries
- Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF), GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE), Training & Competency Programs for GxP Compliance (HLAGAKAM)
Keywords
Where LFH Regulatory Limited is headquartered
LocationHeadquarters
- HQ city
- Leeds (Yeadon)
- HQ country
- United Kingdom
- HQ region
- Europe
Offices2 records
Markets served
LFH Regulatory Limited business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Regulatory Consulting Services: LFH Regulatory charges for expert consulting services across regulatory strategy, quality management systems, clinical evaluation, technical documentation, and training. Revenue is generated through project-based engagements, retainer arrangements, and professional service fees. No public pricing is listed; engagements are handled via direct consultation and quote-based engagement.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Other | Project-based professional consulting — no standardised public pricing tiers |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels6 records
LFH Regulatory Limited product offering
Product offeringCore offering
LFH Regulatory Limited is a UK-based professional consultancy that provides regulatory, quality, and clinical consulting services to medical device and in vitro diagnostics (IVD) manufacturers. Services span the full product lifecycle — from regulatory strategy and market access, technical file compilation, risk management, biological evaluation, ISO 13485/MDSAP QMS implementation, clinical and performance evaluation, to UK Responsible Person and EU Authorised Representative mandates, global registrations, and tailored training. Clients range from early-stage MedTech startups to global manufacturers seeking CE marking, UKCA marking, and FDA pathway support.
Product overview
LFH Regulatory Limited is a regulatory consultancy firm offering a comprehensive suite of services for medical device and IVD manufacturers. The company operates as a unified consultancy service (not a software product platform) providing regulatory, quality, clinical, and training services. Core service categories include: Regulatory Services (Technical File, Risk Management, Biological Evaluation, Regulatory Strategy, Regulatory Intelligence), Quality Services (QMS Implementation, QMS Packages), Clinical Services (Clinical Evaluation, Performance Evaluation for IVDs), Authorised Representative Services (UK Responsible Person, EU Authorised Representatives), and sector-specialised consulting for Medical Devices, Software as a Medical Device (SaMD), In Vitro Diagnostics, and Start-Ups. Additional services include ISO 27001, DTAC/Clinical Risk, Global Registrations, and Training Solutions.
Differentiator
Problem solved
Functional benefit
Products and services
- Technical File Services Development and compilation of technical documentation required for medical device regulatory submissions, including design history files and compliance evidence for CE marking and UKCA marking.
- Risk Management Risk management services aligned with ISO 14971, covering hazard identification, risk assessment, and risk control measures throughout the product lifecycle for medical device manufacturers.
- Biological Evaluation Evaluation of biological safety for medical devices in accordance with the ISO 10993 series, assessing biocompatibility and potential risks from device materials.
- Regulatory Strategy and Market Access Strategic consultancy services guiding medical device and IVD manufacturers through regulatory pathways for EU MDR, UK MDR, FDA, and international market entry.
- Regulatory Intelligence Services Monitoring and analysis of evolving regulatory requirements and guidance documents to maintain compliance with changing medical device and IVD regulations.
- QMS Implementation (ISO 13485 and MDSAP) Quality Management System implementation services for medical device manufacturers, aligned with ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP) requirements.
- Clinical Evaluation Clinical evaluation services for medical devices, including Clinical Evaluation Report (CER) development in accordance with EU MDR Article 61 and Annex XIV.
- Performance Evaluation for IVDs Performance evaluation services for In Vitro Diagnostics (IVDs) covering scientific validity, analytical performance, and clinical performance per IVDR 2017/746 requirements.
- UK Responsible Person Services Authorised representative services for non-UK manufacturers requiring a UK Responsible Person under UK MDR 2002 for market access.
- EU Authorised Representative Services EU authorised representative services for non-EU manufacturers seeking market access under EU MDR 2017/745 and IVDR 2017/746.
- ISO 27001 Services Information security management system services aligned with ISO 27001 for medical device and healthcare technology companies.
- DTAC and Clinical Risk Services NHS Digital Technology Assessment Criteria (DTAC) compliance services and clinical risk management aligned with DCB0129 for digital health technologies.
- Global Registration Services International regulatory registration services supporting market entry across global jurisdictions including EU, UK, US, and other international markets, from feasibility assessment through lifecycle management.
- Training Solutions Regulatory and quality management training programmes covering EU MDR, IVDR, ISO 13485, risk management, and other medical device regulatory topics, including custom training for client teams.
- Software as a Medical Device (SaMD) Consultancy Specialised consultancy for software-based medical devices, including AI/ML-enabled medical device regulatory compliance, IEC 62304 software lifecycle support, and clinical evaluation for SaMD.
Companies that use LFH Regulatory Limited
Customer profileNamed customers5 records
Segments4 records
Ideal customer profiles3 records
LFH Regulatory Limited technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
LFH Regulatory Limited partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Health Tech World AwardsminorLFH Regulatory acted as a judging partner in the Startup of the Year category at the Health Tech World Awards 2025, reviewing entries from health tech startups. This partnership raises the company's profile within the health tech and MedTech ecosystem and demonstrates industry thought leadership.
Scale indicators2 records
Recent moves5 records
Expansion highlights6 records
LFH Regulatory Limited competitors and assessment
Company assessmentDirect peers
- Maetrics: Maetrics is a specialist medical device and IVD regulatory and quality compliance consultancy offering QMS, ISO 13485, technical file and EU Authorised Representative services — a direct competitor to LFH in the same niche.
- Mantra Systems: Mantra Systems is a UK-based medical device regulatory consultancy providing Clinical Evaluation Reports, technical file support and MDR/IVDR consulting — closely comparable to LFH in geography, size and service mix.
- Brandwood CKC: Brandwood CKC is an Australia/UK-based medical device regulatory and quality consulting firm offering MDR/IVDR, TGA and FDA pathway support. Comparable in scope to LFH though operating across Asia-Pacific as well.
- MedEnvoy: MedEnvoy is a specialist EU Authorised Representative and UK Responsible Person service provider for medical device and IVD manufacturers. Directly comparable to LFH on its recurring Authorised Representative services.
- IMed Consultancy: IMed Consultancy is a UK-based medical device and IVD regulatory consultancy offering CE/UKCA marking, technical documentation and QMS services — a comparable boutique competitor to LFH in the UK market.
- Ogyris Consulting: Ogyris is a UK-based medical device regulatory consultancy providing quality, clinical and regulatory services for SaMD and IVD companies — directly comparable to LFH on SaMD and digital health regulatory support.
- RQM+ (formerly R&Q Group): RQM+ is a specialist medical device and IVD regulatory, quality, and clinical consulting firm with global operations. It directly overlaps with LFH Regulatory across MDR/IVDR consulting, technical files, QMS implementation and clinical evaluation, but operates at significantly larger scale.
- Advena Medical: Advena Medical is a regulatory consultancy specialising in medical device and IVD compliance, including UK Responsible Person and EU Authorised Representative services — a comparable specialist peer in the same niche.
Broad incumbents
- NAMSA: NAMSA is a large medical device-focused CRO and regulatory consultancy offering testing, regulatory and quality services globally. It overlaps with LFH in MDR/IVDR consulting and biological evaluation but operates across a much broader service portfolio.
- Freyr Solutions: Freyr is a global regulatory solutions provider covering medical devices, pharma, and consumer products, including MDR/IVDR submissions and global registrations. Comparable in regulatory-submission capabilities though larger and broader in scope.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
LFH Regulatory Limited social profiles
Digital presenceLFH Regulatory Limited financial estimates
Financial estimateRevenue estimate
Valuation estimate
LFH Regulatory Limited leadership team
Management profileNumber of profiles
Profiles7 records
LFH Regulatory Limited funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
LFH Regulatory Limited M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about LFH Regulatory Limited
What does LFH Regulatory Limited do?
LFH Regulatory Limited is a UK-based professional consultancy that provides regulatory, quality, and clinical consulting services to medical device and in vitro diagnostics (IVD) manufacturers. Services span the full product lifecycle — from regulatory strategy and market access, technical file compilation, risk management, biological evaluation, ISO 13485/MDSAP QMS implementation, clinical and performance evaluation, to UK Responsible Person and EU Authorised Representative mandates, global registrations, and tailored training. Clients range from early-stage MedTech startups to global manufacturers seeking CE marking, UKCA marking, and FDA pathway support.
Is LFH Regulatory Limited a public or private company?
LFH Regulatory Limited is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was LFH Regulatory Limited founded?
LFH Regulatory Limited was founded in 2019. It employs 1 to 10 people.
Where is LFH Regulatory Limited based?
LFH Regulatory Limited is headquartered in Leeds (Yeadon), United Kingdom, in the Europe region.
How does LFH Regulatory Limited make money?
One revenue line is on record: regulatory Consulting Services.
Who are LFH Regulatory Limited's main competitors?
Direct peers on record are Maetrics, Mantra Systems, Brandwood CKC, MedEnvoy, IMed Consultancy, Ogyris Consulting, RQM+ (formerly R&Q Group) and Advena Medical. Broad incumbents are NAMSA and Freyr Solutions.
Does LFH Regulatory Limited have an API?
No public API is recorded for LFH Regulatory Limited.
What industry is LFH Regulatory Limited in?
LFH Regulatory Limited's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of HLAGAKAF, Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA). Its NAICS code is 5417 and its SIC code is 8731.