Mantra Systems
Mantra Systems is a Sheffield-based medical device regulatory consultancy, founded in 2019, that helps manufacturers achieve UKCA, CE-marking under EU MDR/IVDR, FDA 510(k), and SaMD certification through expert consulting, CEP/CER writing, and QMS support.
- Company typePrivate
- Founded2019
- HeadquartersSheffield, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Mantra Systems does
Mantra Systems Ltd is a privately held medical device regulatory consultancy headquartered in Sheffield, United Kingdom, founded in 2019 and operating with 11-50 employees. The firm supports medical device manufacturers across all risk classes (Class I, IIa, IIb, III) and Software as a Medical Device (SaMD) developers in achieving UKCA, CE-marking under EU MDR, IVDR, and related US-to-EU market access pathways. Its service portfolio spans six core offerings: UK & EU MDR Consulting, Clinical Evaluation (CEP & CER) writing, IVDR Consulting, SaMD Accelerated Approval, US-to-EU Market Access, and the QMS Jumpstart ISO 13485 quality management system platform. The company claims a 100% submission success rate under EU MDR and EU IVDR and 250+ successful CEP/CER submissions spanning all risk classes, with named clients including Northgate Technologies, LifeSignals, Procter & Gamble, and Cardioline.
Revenue is generated primarily through project-based regulatory consulting fees that vary with device class and complexity, complemented by a small self-serve revenue line from the £145 Medical Affairs Training Course sold through a dedicated resources hub. The go-to-market is sales-led and consultative: same-day quotations are issued against inbound enquiries from pre-market startups through to stockmarket-listed multinationals. Demand generation is content-led, anchored by 90+ SEO articles, white papers, document templates, a free MDR Compliance Checker, and the 2025-launched EnableChat AI chatbot for natural-language search across MDR and MDCG documents. The firm maintains strategic partnerships with Cyber Alchemy (joint regulatory-cybersecurity webinars and reviews) and Franklyn Health (clinical trial content), alongside unnamed EC REP / UKRP / CH-REP referral relationships. Mantra is ISO 9001:2015 registered, a TOPRA member, and a member of the NHS Clinical Entrepreneur Programme; no external funding, M&A, parent company, or ownership disclosures have been made.
Mantra Systems firmographics
Firmographics- Name
- Mantra Systems
- Legal name
- Mantra Systems Ltd
- Website
- https://mantrasystems.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Mantra Systems is a Sheffield-based medical device regulatory consultancy, founded in 2019, that helps manufacturers achieve UKCA, CE-marking under EU MDR/IVDR, FDA 510(k), and SaMD certification through expert consulting, CEP/CER writing, and QMS support.
- Ownership category
- akta.pro rank
Mantra Systems industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Other Scientific and Technical Consulting Services (54169), Computer Systems Design Services (541512)
- SIC
- Services-Health Services (8000), Services-Prepackaged Software (7372)
- akta.pro primary industry
- Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)
- akta.pro secondary industry
- Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL)
Keywords
Where Mantra Systems is headquartered
LocationHeadquarters
- HQ city
- Sheffield
- HQ country
- United Kingdom
- HQ region
- Europe
Offices1 record
Markets served
Mantra Systems business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure
Revenue model
- Regulatory Consulting Services: Consulting engagements for UK & EU MDR/IVDR compliance, clinical evaluation, SaMD accelerated approval, US to EU market access, and QMS Jumpstart. Revenue is generated through project-based consulting fees tailored to device class and complexity. This is the primary revenue stream.
- Online Training Courses: Medical Affairs Training Course sold as a one-time payment for lifetime access. Single course priced at £145 (excluding VAT). Provides 3 hours of video content, downloads, post-course exercises, and a Certificate of Completion with CPD points.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Annual | Medical Affairs Training Course - Single payment for lifetime access |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels7 records
Mantra Systems product offering
Product offeringCore offering
Mantra Systems is a medical device regulatory consultancy that helps manufacturers achieve and maintain UKCA, CE-marking, and FDA-related compliance for physical and software medical devices. Its core offering consists of project-based consulting services covering EU MDR/IVDR pathway strategy, Clinical Evaluation Protocol and Report (CEP/CER) writing, SaMD accelerated approval, US-to-EU market access leveraging FDA 510(k) clearance, and the QMS Jumpstart ISO 13485 quality management platform. The company supplements its consulting with an AI chatbot (EnableChat), a free MDR compliance checker, and a paid Medical Affairs online training course.
Product overview
Mantra Systems is a medical device regulatory consulting company offering a comprehensive portfolio of regulatory strategy and technical documentation services for UK and EU MDR/IVDR pathways. The core offering consists of six main consulting service lines: UK & EU MDR Consulting, Clinical Evaluation (CEP & CER Writing), IVDR Consulting, SaMD Accelerated Approval, US to EU Market Access, and QMS Jumpstart (an ISO 13485-compliant Quality Management System platform). The company also provides specialized solutions tailored for different device risk classes (Class I, IIa/IIb, Class III, and SaMD) and MDD to MDR transition support. Additionally, Mantra Systems offers educational resources including a Medical Affairs Training Course, free MDR Compliance Checker tool, AI-powered EnableChat chatbot for regulatory document search, and various white papers, guides, and document templates. The company has a 100% submission success rate under both EU MDR and EU IVDR, with over 250+ clinical evaluation submissions across all risk classes.
Differentiator
Problem solved
Functional benefit
Products and services
- UK & EU MDR Consulting Tailored regulatory consulting services to secure UKCA or CE-marking for medical devices under UK and EU Medical Device Regulations, designed for manufacturers across all device classes and clinical fields.
- Clinical Evaluation (CEP & CER Writing) Complete Clinical Evaluation Protocol and Clinical Evaluation Report writing service covering literature search, state-of-the-art reviews, and submission documentation, with a track record of 250+ successful CEP/CER submissions across all risk classes.
- IVDR Consulting In Vitro Diagnostic Regulatory consulting to help IVD manufacturers achieve first-time IVDR approval, including performance evaluation, scientific validity, and technical documentation support.
- SaMD Accelerated Approval Software as a Medical Device certification services tailored for time-critical market entry scenarios, combining regulatory strategy, IEC 62304-aligned documentation, and cybersecurity evidence support.
- US to EU Market Access Programme that leverages an existing FDA 510(k) clearance to accelerate UK and European certification under MDR and IVDR, including bridging clinical evidence, labelling, and language requirements.
- QMS Jumpstart All-in-one Quality Management System platform designed to ensure compliance with ISO 13485 requirements for medical device manufacturers operating under EU MDR/IVDR.
- Medical Affairs Training Course Self-paced online training course developing essential medical affairs and regulatory capabilities, including EU MDR and applied literature reviewing, delivered via the resources.mantrasystems.com platform.
Quantifiable outcome
- 250+ successful CEP/CER submissions spanning all risk classes
- +2 more outcomes
Companies that use Mantra Systems
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles4 records
Mantra Systems technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature2 records
Mantra Systems partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and minor.
- Cyber AlchemycoreMantra Systems and Cyber Alchemy have an ongoing strategic co-development partnership producing a joint practical series for MedTech teams on regulatory and cybersecurity compliance. They co-author articles (e.g., non-conformity recovery series), offer joint free 30-minute reviews, and present combined webinars on regulatory and cybersecurity essentials for medical device software and AI-enabled devices. Mantra Systems specializes in regulatory strategy and technical documentation; Cyber Alchemy focuses on cybersecurity for software-enabled and connected medical devices.
- Franklyn HealthminorFranklyn Health collaborated with Mantra Systems on a guest article about clinical trial design for medical device development. Franklyn Health contributes clinical operations expertise to the partnership.
- EU Authorized Representative / UK Responsible Person PartnersminorMantra Systems maintains close working relationships with carefully selected partners that can act as EU Authorised Representative (EC REP), UK Responsible Person (UKRP), or Swiss Authorised Rep (CH-REP) for non-EU medical device manufacturers. These partners are not named specifically.
Scale indicators3 records
Recent moves6 records
Expansion highlights6 records
Mantra Systems competitors and assessment
Company assessmentDirect peers
- Maetrics: Maetrics is a specialist life sciences quality and regulatory compliance consultancy serving medical device and pharma clients - comparable services mix in QMS, ISO 13485, and clinical evaluation support.
- NAMSA: NAMSA combines medical device testing and regulatory consulting, including clinical evaluation and market access services - directly comparable on integrated testing-plus-regulatory positioning for medical device manufacturers.
- Procedural Consulting: Procedural Consulting is a regulatory affairs boutique working on medical device submissions, clinical evaluation, and international market access - a comparable specialized MDR/IVDR consultancy.
- Medidee Services: Medidee Services is a medical device-focused regulatory and quality consulting firm specializing in EU MDR and IVDR; comparable service portfolio and customer segment to Mantra Systems.
- RQM+: RQM+ is a regulatory and quality consulting firm focused on medical devices and IVDs, providing clinical evaluation, QMS, and submission support - closely aligned with Mantra Systems' core service lines and customer base.
- IMed Consultancy: IMed Consultancy is a UK-based regulatory affairs consultancy specializing in EU MDR/IVDR and UKCA compliance for medical device manufacturers, competing head-to-head with Mantra in clinical evaluation and CE/UKCA marking work.
Emerging players
- RegDesk: RegDesk is a software-driven regulatory intelligence and compliance platform for medical devices and IVDs - intersects with Mantra's QMS Jumpstart and EnableChat tooling and overlaps with parts of its service offering.
Broad incumbents
- TÜV SÜD: TÜV SÜD is a global testing, inspection, and certification body with a Notified Body designation and medical device consulting practice that competes with specialist EU MDR consultancies including Mantra.
- BSI Group: BSI is a major global Notified Body that also offers regulatory and ISO 13485 advisory services - overlapping with Mantra's consulting practice but with far broader certification and standards scope.
- DEKRA: DEKRA is a large international Notified Body offering certification and advisory services for medical devices under MDR/IVDR - a broader incumbent with overlapping regulatory consulting capabilities.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks5 records
Key highlights7 records
Customer concentration
Mantra Systems social profiles
Digital presenceMantra Systems compliance and trust
Trust signalCompliance3 records
Mantra Systems financial estimates
Financial estimateRevenue estimate
Valuation estimate
Mantra Systems leadership team
Management profileNumber of profiles
Profiles4 records
Mantra Systems funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Mantra Systems 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 Mantra Systems
What does Mantra Systems do?
Mantra Systems is a medical device regulatory consultancy that helps manufacturers achieve and maintain UKCA, CE-marking, and FDA-related compliance for physical and software medical devices. Its core offering consists of project-based consulting services covering EU MDR/IVDR pathway strategy, Clinical Evaluation Protocol and Report (CEP/CER) writing, SaMD accelerated approval, US-to-EU market access leveraging FDA 510(k) clearance, and the QMS Jumpstart ISO 13485 quality management platform. The company supplements its consulting with an AI chatbot (EnableChat), a free MDR compliance checker, and a paid Medical Affairs online training course.
Is Mantra Systems a public or private company?
Mantra Systems is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Mantra Systems founded?
Mantra Systems was founded in 2019. It employs 11 to 50 people.
Where is Mantra Systems based?
Mantra Systems is headquartered in Sheffield, United Kingdom, in the Europe region.
How does Mantra Systems make money?
Two revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are online Training Courses.
Who are Mantra Systems's main competitors?
Direct peers on record are Maetrics, NAMSA, Procedural Consulting, Medidee Services, RQM+ and IMed Consultancy. RegDesk is listed as an emerging player. Broad incumbents are TÜV SÜD, BSI Group and DEKRA.
Does Mantra Systems have an API?
No public API is recorded for Mantra Systems.
What industry is Mantra Systems in?
Mantra Systems's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAH, Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF), with a secondary code of HLAGAJAL, Regulatory Information Management (RIM) & Submission Publishing Software. Its NAICS code is 54169 and its SIC code is 8000.