RED MEDTECH
Red Medtech is a UK-based medical device consultancy founded in 2021 by Professor Laurie Rowe, providing ISO 13485 quality systems, CE/UKCA/FDA regulatory submissions, technical file authoring, and UKRP/PRRC services to device innovators and manufacturers globally.
- Company typePrivate
- Founded2021
- HeadquartersCarmarthen, United Kingdom
- Headcount1–10
- GTM typeB2B
- OfferingServices
What RED MEDTECH does
Red Medtech Ltd is a privately-held, founder-owned medical device consultancy headquartered in Swansea, Wales, United Kingdom, operating since 2021 under the leadership of Professor Laurie Rowe. The firm specializes exclusively in medical device and diagnostics consulting, delivering an integrated suite of professional services spanning new product development (NPD) project leadership, engineering design for compliance, ISO 13485 quality management system implementation and auditing, regulatory submissions for UK, EU, and US markets (CE marking, UKCA, FDA 510(k)/PMA, MDSAP), Technical File and Design History File creation and remediation, and statutory appointments including UK Responsible Person (UKRP) and Person Responsible for Regulatory Compliance (PRRC) under EU MDR/IVDR.
The company's underlying capability is built on the founder's 20+ years of practical experience in medical device engineering and manufacturing, his role as a BSI Committee Member contributing to multiple international BS, EN, IEC, and ISO medical device standards, and a multi-disciplinary team covering embedded systems (IEC 60601 / IEC 62304 / ISO 14971), human factors (IEC 62366-1), wearables/femtech performance technology, and clinical advisory. Red Medtech is differentiated by a 'design for compliance' methodology applied from concept through post-market support, a documented track record of remediating 50+ Technical Files under the new EU MDR, and Design/Development support for Class III implants achieving CE market clearance.
Commercially, Red Medtech operates a sales-led, professional services model with global reach from its Welsh base, reaching prospective clients via direct consultative sales, free 30-minute Calendly consultations, industry events (Med-Tech Innovation Expo 2026), online project-initiation forms, and founder-led LinkedIn thought leadership. Revenue is generated through quote-based, pay-as-you-go engagements billed to clients ranging from micro-start-ups and university spin-outs to large international manufacturers, with named customers across diverse device categories including insulin cartridge commercialization (Forbion/Cellnovo), post-Brexit UKCA compliance (Made for Movement), wearables, wound care, veterinary devices, and surgical instruments. The company is unfunded, profitable on a consultancy basis, and positioned in the UK MDR/EU MDR regulatory tailwind.
RED MEDTECH firmographics
Firmographics- Name
- RED MEDTECH
- Legal name
- Red Medtech Ltd
- Website
- https://redmedtech.co.uk
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Red Medtech is a UK-based medical device consultancy founded in 2021 by Professor Laurie Rowe, providing ISO 13485 quality systems, CE/UKCA/FDA regulatory submissions, technical file authoring, and UKRP/PRRC services to device innovators and manufacturers globally.
- Ownership category
- akta.pro rank
RED MEDTECH industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Medical Writing & Clinical Documentation FSP (HLAGAOAC)
- akta.pro secondary industry
- Life Sciences & Biotech (R&D/Clinical) Staffing (BPACADAL)
Keywords
Where RED MEDTECH is headquartered
LocationHeadquarters
- HQ city
- Carmarthen
- HQ country
- United Kingdom
- HQ region
- Europe
Offices1 record
Markets served
RED MEDTECH business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Medical Device Consulting Services: Professional consulting services for medical device development projects including project management, regulatory compliance, quality management systems, and technical documentation. Revenue is generated through service engagements billed to clients seeking regulatory and development expertise.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Free Initial Meeting - 30 minute consultation |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels4 records
RED MEDTECH product offering
Product offeringCore offering
RED MEDTECH is a technical, regulatory, and quality consultancy specializing in medical devices. It provides consulting for medical device product development, project management, regulatory submissions, ISO 13485 quality management systems, technical documentation, CE/UKCA marking, UKRP, and PRRC services.
Product overview
RED MEDTECH is a medical device consultancy that offers an integrated suite of consulting services rather than a traditional software product. The core service portfolio comprises four interconnected offerings: Product Development Consulting (covering NPD from concept to market), Project Guidance (program and project management), Quality ISO 13485 Services (QMS implementation and auditing), and Regulatory Compliance Services (CE/UKCA/FDA submissions). Supporting these are specialized regulatory services including UKRP and PRRC appointments, and Technical Files/DHF documentation services. All services are delivered by consultants with over 20 years of hands-on medical device engineering and manufacturing experience, and the company specializes in transition support from legacy MDD to new EU MDR regulations.
Differentiator
Problem solved
Functional benefit
Products and services
- Product Development Consulting
- Project Guidance
- Quality ISO 13485 Services
- Regulatory Compliance Services
- UK Responsible Person (UKRP)
- Person Responsible for Regulatory Compliance (PRRC)
- Technical Files and DHF Services
Quantifiable outcome
- Successfully remediated 50+ Technical Files to new EU Medical Device Regulations while maintaining essential ICU products on market during Covid pandemic
- +1 more outcomes
Companies that use RED MEDTECH
Customer profileNamed customers10 records
Segments3 records
Ideal customer profiles3 records
RED MEDTECH technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
RED MEDTECH partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- Greenlight GurucoreMembership in Greenlight Guru's medical device quality management ecosystem. Greenlight Guru is a leading eQMS provider for medical devices, and this alliance positions Red Medtech as a preferred consulting partner for their shared client base seeking regulatory and quality compliance support.
- MedilinkcoreActive membership in Medilink, the healthcare technology industry association supporting innovation and business growth in the medtech sector.
- British Healthcare Trades Association (BHTA)coreMembership in BHTA, the largest healthcare trades association in the UK, demonstrating commitment to industry standards and ethical trading practices in healthcare technology.
- MediWalesminorMembership in MediWales, the Welsh health and care industry network providing connections and support for healthcare technology companies in Wales.
- Regulatory Affairs Professionals Society (RAPS)minorFounder and team members maintain professional membership in RAPS, the leading global organization for regulatory affairs professionals in healthcare products.
- Institute of Physics and Engineering in Medicine (IPEM)minorProfessional membership in IPEM, the professional organization for physics, engineering and computing professionals working in medicine and biology.
- Institution of Engineering Designers (IED)minorProfessional membership in IED, the professional body for engineering designers.
Scale indicators3 records
Recent moves7 records
Expansion highlights6 records
RED MEDTECH competitors and assessment
Company assessmentDirect peers
- Emergo by UL: Global medical device regulatory and quality consulting business covering FDA, EU MDR, UKCA, MDSAP and ISO 13485. Direct competitor in the same niche of multi-jurisdiction regulatory support for device manufacturers.
- The FDA Group: Regulatory, quality and compliance consultancy for FDA-regulated industries including medical devices. Comparable service lines (QMS implementation, audit prep, remediation) and target customer base.
- Validant: Specialist regulatory affairs and quality compliance consultancy for medical device and combination product companies. Closely comparable in scope (regulatory strategy, submissions, QMS) and client profile (small/mid medtech innovators).
- RQM+: Medical device regulatory and quality consulting firm offering remediation, QMS, clinical and submission services to medtech manufacturers. Most directly comparable peer given similar focus on EU MDR/ISO 13485 remediation and technical file services.
- MDC Associates: Medical device compliance consultancy providing QMS, regulatory submissions and technical file services to medtech manufacturers. Similar size and boutique character to Red Medtech with overlapping service portfolio.
Broad incumbents
- NSF: Large global testing, inspection and certification organisation with a dedicated medical device consulting practice covering regulatory affairs, QMS and product development. Overlaps with Red Medtech's regulatory/QMS services but as part of a much wider portfolio.
- TÜV SÜD: Global testing, certification and compliance consultancy with deep medical device practice including EU MDR Notified Body services, ISO 13485 audits and regulatory consulting. Competes on enterprise multi-jurisdiction programmes.
- IQVIA: Global life sciences services and technology company with regulatory affairs and quality compliance offerings spanning medical devices and pharma. Comparable in regulatory/QMS service lines but at enterprise scale with a different delivery model.
- Parexel International: Large CRO with a regulatory and medical device consulting practice serving global life sciences companies. Overlaps on regulatory affairs and quality services but primarily serves larger pharma/biotech clients.
- BSI Group: Standards body and Notified Body that also offers medical device consultancy and training across ISO 13485 and MDR. Comparable domain expertise and standards authority, but at vastly greater scale.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
RED MEDTECH social profiles
Digital presenceRED MEDTECH financial estimates
Financial estimateRevenue estimate
Valuation estimate
RED MEDTECH leadership team
Management profileNumber of profiles
Profiles1 record
RED MEDTECH funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
RED MEDTECH 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 RED MEDTECH
What does RED MEDTECH do?
RED MEDTECH is a technical, regulatory, and quality consultancy specializing in medical devices. It provides consulting for medical device product development, project management, regulatory submissions, ISO 13485 quality management systems, technical documentation, CE/UKCA marking, UKRP, and PRRC services.
Is RED MEDTECH a public or private company?
RED MEDTECH is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was RED MEDTECH founded?
RED MEDTECH was founded in 2021. It employs 1 to 10 people.
Where is RED MEDTECH based?
RED MEDTECH is headquartered in Carmarthen, United Kingdom, in the Europe region.
How does RED MEDTECH make money?
One revenue line is on record: medical Device Consulting Services.
Who are RED MEDTECH's main competitors?
Direct peers on record are Emergo by UL, The FDA Group, Validant, RQM+ and MDC Associates. Broad incumbents are NSF, TÜV SÜD, IQVIA, Parexel International and BSI Group.
Does RED MEDTECH have an API?
No public API is recorded for RED MEDTECH.
What industry is RED MEDTECH in?
RED MEDTECH's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAOAC, Medical Writing & Clinical Documentation FSP, with a secondary code of BPACADAL, Life Sciences & Biotech (R&D/Clinical) Staffing. Its NAICS code is 54171 and its SIC code is 8731.