MedQtech
MedQtech is a Sweden-based medical device consultancy (founded 2016) that provides EU and US regulatory compliance and quality management services to medical device companies, bundled with its proprietary MedQdoc cloud-based eQMS platform containing 130+ pre-validated templates.
- Company typePrivate
- Founded2016
- HeadquartersGrebbestad, Sweden
- Headcount1–10
- GTM typeB2B
- OfferingServices
What MedQtech does
MedQtech AB is a Sweden-based medical device consultancy founded in 2016, operating from Grebbestad (HQ) and Sundsvall, with 1-10 employees. The firm serves medical device companies requiring regulatory compliance and quality management support across EU (MDR 2017/745, IVDR 2017/746, CE marking, ISO 13485, ISO 14971) and US (FDA QSR) frameworks, and offers two core service lines: Regulatory Compliance Services (CE marking, classification, gap analysis, regulatory strategy, PRRC representation, EU/US registrations) and Quality Management Services (QMS implementation, ISO 13485 readiness, QSR compliance, ISO 14971 risk facilitation, ongoing QMS maintenance).
The company's core technology asset is MedQdoc, a proprietary cloud-based electronic Quality Management System (eQMS) validated for the medical device industry, containing over 130 pre-validated ready-to-use templates, step-by-step workflow guidance, and integrated document control. MedQdoc is ISO 13485:2016 certified and is sold alongside consulting engagements, enabling a single-vendor procurement model. The firm is itself ISO 13485:2016 certified.
MedQtech's revenue model combines professional services (project-based regulatory and quality consulting, including PRRC representation and ongoing advisory retainers) with a recurring MedQdoc eQMS subscription line, both sold through quote-based consultative engagements acquired via the website and direct outreach. Pricing is not publicly disclosed, and the firm relies on content marketing (Knowledge Hub blog with named specialist authors), LinkedIn presence, and SEO-driven organic traffic for demand generation. No channel partners, resellers, or institutional investors are disclosed.
MedQtech firmographics
Firmographics- Name
- MedQtech
- Legal name
- MedQtech AB
- Website
- https://medqtech.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- MedQtech is a Sweden-based medical device consultancy (founded 2016) that provides EU and US regulatory compliance and quality management services to medical device companies, bundled with its proprietary MedQdoc cloud-based eQMS platform containing 130+ pre-validated templates.
- Ownership category
- akta.pro rank
MedQtech industry classification
Industry- Product category
- Medical Device Regulatory & Quality Management Consultancy
- NAICS
- Other Scientific and Technical Consulting Services (541690), Computer Systems Design and Related Services (54151)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)
- akta.pro secondary industries
- Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG), Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI), Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)
Keywords
Where MedQtech is headquartered
LocationHeadquarters
- HQ city
- Grebbestad
- HQ country
- Sweden
- HQ region
- Europe
Offices2 records
Markets served
MedQtech business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- Regulatory Compliance Consulting Services: MedQtech provides regulatory compliance and quality management consulting services to medical device companies. Services include CE marking process, regulatory applications and registrations (EU/US), classification of medical devices, gap analysis, regulatory strategy, acting as Person Responsible for Regulatory Compliance (PRRC), and project management. The company also offers ongoing advisory support and full project engagements, often starting as discrete projects that evolve into ongoing partnerships.
- Quality Management System Consulting: Quality management system implementation, ISO 13485 certification readiness, QSR (FDA) compliance, facilitation of ISO 14971 risk management, development and maintenance of QMS processes, and acting as quality and regulatory resource. These services are provided both as standalone consulting engagements and in conjunction with the MedQdoc eQMS platform.
- MedQdoc eQMS Software: MedQdoc is a cloud-based eQMS solution with over 130 pre-validated templates designed specifically for the medical device industry. The software is offered as a bundled solution alongside consulting services, allowing customers to get consultancy services and QMS system from the same provider.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels4 records
MedQtech product offering
Product offeringCore offering
MedQtech provides regulatory compliance and quality management consulting services to medical device companies, including CE marking, EU/US regulatory applications, classification, gap analysis, regulatory strategy, PRRC representation, ISO 13485 certification readiness, QSR compliance, ISO 14971 risk management, and QMS implementation. Alongside its consultancy services, MedQtech offers MedQdoc, a cloud-based electronic Quality Management System (eQMS) validated specifically for the medical device industry with over 130 pre-validated templates and step-by-step workflows.
Product overview
MedQtech offers a portfolio of consultancy services combined with its proprietary MedQdoc eQMS platform. MedQdoc is a cloud-based electronic Quality Management System designed specifically for the medical device industry, providing over 130 pre-validated templates and step-by-step workflow capabilities. The company complements its software with two core service offerings: Regulatory Compliance Services (covering CE marking, EU/US registrations, classification, gap analysis, strategy, and PRRC support) and Quality Management Services (covering QMS implementation, ISO 13485/QSR readiness, ISO 14971 risk management facilitation, and ongoing QMS support). This integrated approach allows customers to obtain both consultancy expertise and a validated QMS system from the same provider.
Differentiator
Problem solved
Functional benefit
Brands
- MedQdoc: An eQMS (electronic Quality Management System) solution designed and validated for the medical device industry, featuring over 130 ready-to-use templates, simple step-by-step workflow, designed by compliance experts, and cloud-based flexibility.
Products and services
- MedQdoc A cloud-based electronic Quality Management System (eQMS) designed and validated specifically for the medical device industry. Features over 130 pre-validated ready-to-use templates, step-by-step workflow guidance, document control, version management, and audit preparation capabilities. It enables companies to streamline MDR, IVDR, ISO 13485, ISO 14971, and QSR requirements, and is bundled with MedQtech's consultancy services so customers can get both consultancy and QMS from the same provider.
- Regulatory Compliance Services Consultancy services for medical device companies covering CE marking process, regulatory applications and registrations (EU/US), classification of medical devices, gap analysis, regulatory strategy, acting as Person Responsible for Regulatory Compliance (PRRC), and project management. Engagements can be discrete projects, ongoing advisory support, or full projects that evolve into ongoing partnerships.
- Quality Management Services Consultancy services for medical device companies including quality management system implementation, ISO 13485 certification readiness, QSR (FDA) compliance, facilitation of ISO 14971 risk management, acting as the customer's Quality and Regulatory resource, development and maintenance of QMS processes, and project management. Services are tailored to organization size and needs, serving both start-ups and large global organizations.
Quantifiable outcome
- Accelerated compliance journey for customers, with MedQtech serving as a team extension rather than a barrier
- +2 more outcomes
Companies that use MedQtech
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles3 records
MedQtech technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
MedQtech partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- MedQdoccoreMedQdoc is MedQtech's proprietary eQMS (electronic Quality Management System) solution designed and validated specifically for the medical device industry. MedQtech and MedQdoc operate in close integration, with MedQtech providing consultancy services and MedQdoc providing the QMS software platform. The companies share the same brand family and MedQtech is an authorized partner/distributor of MedQdoc. The relationship is We to Them, where MedQtech acts as the consultancy channel and face to customers for MedQdoc.
- MedQdoccoreMedQdoc is the eQMS platform developed and offered by MedQtech's ecosystem. MedQtech offers MedQdoc alongside its consulting services, allowing customers to get consultancy services and QMS system from the same provider. The platform includes over 130 ready-to-use templates and is ISO 13485:2016 certified.
Scale indicators2 records
Recent moves6 records
Expansion highlights4 records
MedQtech competitors and assessment
Company assessmentDirect peers
- Greenlight Guru: eQMS platform dedicated to medical device quality management and design controls. Same buyer, same regulatory framework (ISO 13485, FDA QSR), and similar template-driven approach.
- Qualio: Cloud-based eQMS purpose-built for the medical device and life sciences industry. Direct overlap with MedQdoc on validated templates, ISO 13485 focus, and target buyer (medical device QA/RA leaders).
- ComplianceQuest: Cloud QMS and eQMS platform with a strong medical device vertical. Competes on the MedQdoc software side and competes for the same MedQtech consulting buyers.
- The FDA Group: Medical device and pharma regulatory/quality consulting firm offering QMS implementation, ISO 13485, and FDA QSR support. Direct consulting-side competitor to MedQtech's professional services arm.
- MasterControl: Enterprise QMS/eQMS vendor serving medical device and life sciences manufacturers. Competes head-to-head with MedQdoc on the software side and overlaps with MedQtech's consulting referral ecosystem.
- SimplerQMS: Validated eQMS specifically designed for medical device companies seeking ISO 13485 and FDA QSR compliance. Same niche, similar template-based value proposition.
- Rimsys: Regulatory information management platform purpose-built for medical device companies. Adjacent to MedQdoc on regulatory workflow (CE marking, registrations, classification) and shares MedQtech's EU/US compliance focus.
Broad incumbents
- Veeva Systems: Large life sciences cloud platform offering Veeva QualityDocs and Vault QMS used by medical device and pharma companies. A much larger incumbent with overlapping eQMS capabilities, though not focused exclusively on medical devices.
- ETQ (Hexagon): Enterprise QMS platform used across manufacturing including medical devices. Overlaps with MedQdoc for larger enterprise accounts but serves a broader industrial quality base.
Emerging players
- RegDesk: Regulatory intelligence and compliance platform for medical device and IVD companies. Emerging competitor in regulatory strategy and registration workflows that overlap with MedQtech's regulatory consulting practice.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
MedQtech social profiles
Digital presenceMedQtech compliance and trust
Trust signalCompliance1 record
MedQtech financial estimates
Financial estimateRevenue estimate
Valuation estimate
MedQtech leadership team
Management profileNumber of profiles
Profiles4 records
MedQtech funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
MedQtech 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 MedQtech
What does MedQtech do?
MedQtech provides regulatory compliance and quality management consulting services to medical device companies, including CE marking, EU/US regulatory applications, classification, gap analysis, regulatory strategy, PRRC representation, ISO 13485 certification readiness, QSR compliance, ISO 14971 risk management, and QMS implementation. Alongside its consultancy services, MedQtech offers MedQdoc, a cloud-based electronic Quality Management System (eQMS) validated specifically for the medical device industry with over 130 pre-validated templates and step-by-step workflows.
Is MedQtech a public or private company?
MedQtech is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was MedQtech founded?
MedQtech was founded in 2016. It employs 1 to 10 people.
Where is MedQtech based?
MedQtech is headquartered in Grebbestad, Sweden, in the Europe region.
How does MedQtech make money?
Three revenue lines are on record. Regulatory Compliance Consulting Services are the primary driver. The others are quality Management System Consulting and medQdoc eQMS Software.
Who are MedQtech's main competitors?
Direct peers on record are Greenlight Guru, Qualio, ComplianceQuest, The FDA Group, MasterControl, SimplerQMS and Rimsys. Broad incumbents are Veeva Systems and ETQ (Hexagon). RegDesk is listed as an emerging player.
Does MedQtech have an API?
No public API is recorded for MedQtech.
What industry is MedQtech in?
MedQtech's product category is Medical Device Regulatory & Quality Management Consultancy. Its primary akta.pro industry code is HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation, with a secondary code of HLAGAKAG, Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11). Its NAICS code is 541690 and its SIC code is 8731.