Easy Medical Device
Easy Medical Device GmbH is a Basel-based regulatory consulting firm that helps medical device, IVD, SaMD, and AI/digital health manufacturers achieve EU MDR, FDA, and UKCA compliance, supported by two proprietary SaaS platforms (EasyIFU and SmartEye eQMS) and an online certification school.
- Company typePrivate
- Founded2017
- HeadquartersBasel, Switzerland
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Easy Medical Device does
Easy Medical Device GmbH is a Basel, Switzerland-based regulatory and quality consulting firm founded in 2017 (incorporated 2019) that specializes exclusively in medical device, in vitro diagnostic (IVD), software-as-a-medical-device (SaMD), and AI/digital health compliance. Its core business is helping manufacturers achieve and maintain regulatory approval across multiple jurisdictions, with explicit service lines in EU MDR and IVDR technical documentation, FDA consulting, UKCA marking, global market access strategy, audit and inspection readiness, quality and risk management system implementation, biocompatibility testing, packaging and labelling compliance, software development support, and authorized representative services for Switzerland, the EU, and the UK. The firm also operates authorized representative and Swiss representative services for foreign manufacturers navigating post-Brexit and Swixit regimes, with delivery offices in Basel, Manchester, Belgium, and Rabat, and a stated footprint across 50+ countries with 100+ companies supported.
The company's technology layer sits on two proprietary SaaS platforms: EasyIFU, launched in 2025, which manages electronic Instructions For Use and labelling digitally to ensure traceability and faster regulator approvals; and SmartEye eQMS, launched in 2024, which automates quality management system processes, audits, and regulatory reporting. These platforms sit alongside an educational and content ecosystem — the Easy Medical Device School (offering paid certifications such as the EU MDR Green Belt), a long-running YouTube channel, podcast, blog, magazines, and the MedTech Conf industry event launched in 2024 — that functions as both a marketing channel and a freemium-to-paid training funnel.
Commercially, Easy Medical Device combines a sales-led motion (free discovery calls, book-a-call, quote-based consulting contracts, often multi-year) with subscription and one-time licensing revenue from its School platform and Software-as-a-Service revenue from EasyIFU and SmartEye eQMS. Pricing is quote-based for consulting and ranges from free introductory mini-courses to paid certifications and individual training products (e.g., a vigilance reporting course priced at €49). The firm remains privately held, founder-led by CEO Monir El Azzouzi, bootstrapped with no disclosed external funding, and operates with a small core team of approximately 11 named professionals spanning regulatory, quality, biomedical engineering, software development, and digital marketing functions.
Easy Medical Device firmographics
Firmographics- Name
- Easy Medical Device
- Legal name
- Easy Medical Device GmbH
- Website
- https://easymedicaldevice.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Easy Medical Device GmbH is a Basel-based regulatory consulting firm that helps medical device, IVD, SaMD, and AI/digital health manufacturers achieve EU MDR, FDA, and UKCA compliance, supported by two proprietary SaaS platforms (EasyIFU and SmartEye eQMS) and an online certification school.
- Ownership category
- akta.pro rank
Easy Medical Device industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Testing Laboratories and Services (541380)
- SIC
- Services-Health Services (8000)
- akta.pro primary industry
- Clinical Coding Support (ICD/CPT/SNOMED) & Documentation Compliance Tools (HLACAAAO)
- akta.pro secondary industry
- EHR Extensions, APIs, App Marketplaces & SMART-on-FHIR Apps (HLACAAAN)
Keywords
Where Easy Medical Device is headquartered
LocationHeadquarters
- HQ city
- Basel
- HQ country
- Switzerland
- HQ region
- Europe
Offices4 records
Markets served
Easy Medical Device business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- Regulatory Consulting Services: Professional consulting services for medical device regulatory compliance including EU MDR, FDA, UKCA, market access strategy, technical documentation, quality management systems, and audit readiness.
- Online Training Courses: Educational courses including EU MDR Green Belt certification, vigilance reporting training, audit readiness courses, and mini-courses delivered through the Easy Medical Device School platform.
- Software Platform Subscriptions: Subscription-based access to EasyIFU and SmartEye eQMS platforms for digital compliance management.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Freemium | One-time | Free Mini-Course (6-day email course) providing overview of EU MDR 2017/745 |
| Subscription | One-time | Green Belt EU MDR 2017/745 Certification courses (multiple editions) |
| One time/ perpetual license | One-time | Vigilance Reporting EU Legislation eTraining |
| Other | Multi-year contract | Regulatory Consulting Services |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels7 records
Easy Medical Device product offering
Product offeringCore offering
Easy Medical Device is a regulatory consulting firm that helps medical device, IVD, software-as-a-medical-device, and AI/digital health companies navigate EU MDR, FDA, and UKCA compliance. It delivers regulatory strategy, quality management system implementation, audit readiness, technical documentation, biocompatibility testing support, and authorized representative services, supplemented by two proprietary digital platforms (EasyIFU and SmartEye eQMS) and an online certification school.
Product overview
Easy Medical Device operates a dual offering: two proprietary SaaS platforms (EasyIFU for electronic Instructions For Use management and SmartEye eQMS for digital quality management system automation) complemented by a portfolio of regulatory consulting services including EU MDR, FDA, global market access, audit readiness, quality & risk management, biocompatibility testing, packaging/labeling compliance, medical device software development, and business setup services. The company also operates Easy Medical Device School as an educational platform offering certification courses on EU MDR and regulatory compliance topics.
Differentiator
Problem solved
Functional benefit
Brands
- EasyIFU: Electronic Instructions for Use (eIFU) compliance platform for managing digital IFUs and labeling.
- SmartEye eQMS
- Easy Medical Device School
Products and services
- EasyIFU Platform Digital platform for managing electronic Instructions For Use (eIFUs) and labeling digitally, ensuring compliance, traceability, and faster regulator approvals for medical device manufacturers.
- SmartEye eQMS Platform Digital quality management system (eQMS) that automates QMS processes, streamlines audits, and supports regulatory reporting for faster compliance for medical device companies.
- EU MDR Consulting Expert consulting guidance on EU Medical Device Regulation (EU MDR) compliance for achieving market access in the European Union, for medical device companies.
- FDA Consulting Regulatory consulting services for FDA medical device compliance and US market approval, including 510(k) pathway and FDA submission support.
- Global Market Access Consulting Strategic consulting guidance for navigating regulatory pathways to enter global markets quickly and confidently for medical device companies.
- Audit & Inspection Readiness Preparation services for teams and documentation to confidently pass audits in any international jurisdiction for medical device manufacturers.
- Quality & Risk Management Systems Implementation of compliant QMS and risk management frameworks to ensure smooth audits and minimize business risks for medical device companies.
- Biocompatibility Testing Verification and validation consulting support for medical device biocompatibility testing requirements.
- Packaging & Labeling Compliance Validation of packaging, IFUs, and labels for full regulatory compliance and traceability across markets for medical device manufacturers.
- Medical Device Software Development Software development consulting services for medical devices, aligning development with global standards for safe, timely market approvals (including IEC 62304).
- External Regulatory Team Dedicated external regulatory team support for medical device compliance projects, providing embedded regulatory expertise on an ongoing basis.
- External Quality Team External quality team consulting services for ongoing compliance support and quality system management for medical device companies.
- Medical Device Company Registration Medical device company registration consulting services for market entry support.
- Business Bank Account Opening Business bank account opening consulting services for medical device companies.
- Easy Medical Device School Online learning platform offering paid certification courses (e.g., Green Belt EU MDR) and free mini-courses on EU MDR, regulatory compliance, vigilance reporting, and audit readiness for medical device professionals.
Quantifiable outcome
- 100+ companies supported to achieve regulatory compliance
- +2 more outcomes
Companies that use Easy Medical Device
Customer profileNamed customers8 records
Segments4 records
Ideal customer profiles4 records
Easy Medical Device technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
Easy Medical Device partnerships and signals
Strategic signalScale indicators6 records
Recent moves13 records
Expansion highlights6 records
Easy Medical Device competitors and assessment
Company assessmentDirect peers
- Celegence: Celegence provides regulatory affairs, MDR/IVDR, and clinical documentation services to medical device companies. It is a specialist consulting competitor with similar core services (DMR, technical files, global market access) to Easy Medical Device.
- NAMSA: NAMSA is a medical device-focused consulting, testing, and regulatory services firm that helps manufacturers with biocompatibility, sterilization, and global market access. It competes for the same verification, validation, and regulatory consulting budgets as Easy Medical Device.
- MasterControl: MasterControl sells a full QMS, document management, and compliance platform heavily used by medical device manufacturers. It directly overlaps with SmartEye eQMS and competes for the same regulatory compliance budget as Easy Medical Device's consulting and software offerings.
- Qualio: Qualio provides a cloud eQMS for life sciences and medical device companies, including quality, document, and training management. Like SmartEye eQMS, it digitizes ISO 13485 and 21 CFR Part 820 compliance and is sold to the same medical device QA/RA buyer.
- Greenlight Guru: Greenlight Guru offers an eQMS platform purpose-built for medical device companies, directly competing with SmartEye eQMS. It also provides adjacent regulatory/quality consulting and educational content, serving the same medical device manufacturer buyer as Easy Medical Device.
- RQM+ (formerly Regulatory and Quality Solutions): RQM+ is a medical device regulatory and quality consulting firm providing EU MDR, FDA, and global market access services. It is the closest head-to-head consulting competitor to Easy Medical Device's professional services portfolio.
Broad incumbents
- TÜV SÜD: TÜV SÜD is a global notified body and testing/certification provider for medical devices, including ISO 13485, CE marking, and training. As a broad incumbent, it overlaps with Easy Medical Device's regulatory and quality consulting services but at much greater scale and scope.
- IQVIA: IQVIA provides regulatory, quality, and compliance services to life sciences and medical device manufacturers as part of a broad clinical and commercial services portfolio. It is a much larger incumbent that competes for enterprise regulatory outsourcing budgets.
- BSI Group: BSI is a global standards body and notified body that issues ISO 13485 certifications and provides related regulatory and training services for medical device manufacturers. It is a much larger incumbent covering adjacent certification, training, and consulting services that overlap with Easy Medical Device's offerings.
Others
- IQVIA Regulatory Compliance (formerly Q² Solutions): ComplianceQuest is a QMS and regulatory compliance platform provider for life sciences and medical device companies. It competes with SmartEye eQMS in digitizing quality and document management workflows for the same medical device QA/RA buyer.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Easy Medical Device social profiles
Digital presenceEasy Medical Device compliance and trust
Trust signalCompliance1 record
Easy Medical Device financial estimates
Financial estimateRevenue estimate
Valuation estimate
Easy Medical Device leadership team
Management profileNumber of profiles
Profiles11 records
Easy Medical Device funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Easy Medical Device 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 Easy Medical Device
What does Easy Medical Device do?
Easy Medical Device is a regulatory consulting firm that helps medical device, IVD, software-as-a-medical-device, and AI/digital health companies navigate EU MDR, FDA, and UKCA compliance. It delivers regulatory strategy, quality management system implementation, audit readiness, technical documentation, biocompatibility testing support, and authorized representative services, supplemented by two proprietary digital platforms (EasyIFU and SmartEye eQMS) and an online certification school.
Is Easy Medical Device a public or private company?
Easy Medical Device is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Easy Medical Device founded?
Easy Medical Device was founded in 2017. It employs 11 to 50 people.
Where is Easy Medical Device based?
Easy Medical Device is headquartered in Basel, Switzerland, in the Europe region.
How does Easy Medical Device make money?
Three revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are online Training Courses and software Platform Subscriptions.
Who are Easy Medical Device's main competitors?
Direct peers on record are Celegence, NAMSA, MasterControl, Qualio, Greenlight Guru and RQM+ (formerly Regulatory and Quality Solutions). Broad incumbents are TÜV SÜD, IQVIA and BSI Group. IQVIA Regulatory Compliance (formerly Q² Solutions) is listed as an others.
Does Easy Medical Device have an API?
No public API is recorded for Easy Medical Device.
What industry is Easy Medical Device in?
Easy Medical Device's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLACAAAO, Clinical Coding Support (ICD/CPT/SNOMED) & Documentation Compliance Tools, with a secondary code of HLACAAAN, EHR Extensions, APIs, App Marketplaces & SMART-on-FHIR Apps. Its NAICS code is 541380 and its SIC code is 8000.