confinis
confinis is a Swiss regulatory consulting firm serving medical device, IVD, and combination product manufacturers globally, providing regulatory affairs, quality management, compliance, and training services from offices in Switzerland, the UK, and the USA.
- Company typePrivate
- Founded2005
- HeadquartersDüdingen, Switzerland
- Headcount11–50
- GTM typeB2B
- OfferingServices
What confinis does
confinis is a privately held Swiss regulatory consulting firm founded in 2005 in Düdingen, Switzerland, specializing in regulatory affairs, quality management, and compliance for medical devices, in-vitro diagnostics (IVDs), and combination products. The firm serves a global client base of pharmaceutical, biotech, biosimilar, and medical technology companies — ranging from early-stage startups to established multinational manufacturers — helping them navigate EU MDR/IVDR, FDA, UK, and Swiss regulatory requirements across the full product lifecycle, from regulatory strategy and CE marking through QMS implementation, clinical evaluation, post-market surveillance, and auditing.
The company's service portfolio spans consulting engagements (regulatory affairs, ISO 13485 QMS, combination products, clinical evaluation, cybersecurity, regulated AI, digital health, medical software/SaMD, and EUDAMED/Swissdamed registration), supplemented by two proprietary technology assets: openQMS, an Atlassian-based electronic Quality Management System built on Jira and Confluence, and confinis Academy, a Thinkific-hosted e-learning platform launched in January 2025 that delivers self-paced courses on FDA QMSR, EUDAMED, AI in medical devices, and cybersecurity. The firm maintains wholly owned subsidiaries in the United Kingdom (confinis (UK) RP Ltd, providing UK Responsible Person services) and the United States (confinis USA Inc., based in Durham, NC), and operates as part of the Athagoras group. The team is multidisciplinary — including biomedical, mechanical, electrical, and software engineers alongside physicists, pharmacists, medical doctors, and biologists — led by CEO Dr. Andrea Biasiucci and founder/Chairman Beat U. Steffen (RAPS Fellow, RAC Device certified, 30 years of industry experience including leadership roles at Disetronic and Ypsomed).
Revenue is generated primarily through quote-based professional services engagements with multi-year contracts, with growing contribution from the Academy platform and the firm's roles as Swiss Authorized Representative (CH REP), UK Responsible Person (UK RP), and US Agent — recurring regulatory intermediary mandates. Distribution is principally direct, senior-consultant-led enterprise sales supported by thought-leadership content (white papers, blog posts), industry event participation (RAPS, Swiss Medtech, JPM Healthcare), and a recurring startup workshop program. The firm is privately held by founders and management, with no disclosed external institutional investment.
confinis firmographics
Firmographics- Name
- confinis
- Legal name
- confinis ag
- Website
- https://confinis.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- confinis is a Swiss regulatory consulting firm serving medical device, IVD, and combination product manufacturers globally, providing regulatory affairs, quality management, compliance, and training services from offices in Switzerland, the UK, and the USA.
- Ownership category
- akta.pro rank
confinis industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Other Scientific and Technical Consulting Services (541690), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
Keywords
Where confinis is headquartered
LocationHeadquarters
- HQ city
- Düdingen
- HQ country
- Switzerland
- HQ region
- Europe
Offices3 records
Markets served
confinis business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Regulatory Consulting Services: Professional consulting services covering regulatory affairs strategy, quality management, design control, risk management, usability engineering, clinical evaluation, labeling, manufacturing, process validation, supply chain management, post-market surveillance, and auditing. Services are delivered by senior consultants with decades of hands-on experience.
- Training and Education: E-learning courses and workshops delivered through confinis Academy platform. Includes ISO 13485 compliance courses, EUDAMED/Swissdamed registration training, AI in medical devices, cybersecurity, IEC 62304 software development, clinical evaluation, and FDA regulatory pathways.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Enterprise consulting engagements |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels6 records
confinis product offering
Product offeringCore offering
confinis provides regulatory affairs and quality management consulting services to medical device, in-vitro diagnostic, and combination product manufacturers, covering the full product lifecycle from regulatory strategy and CE/FDA market authorization through QMS implementation, clinical evaluation, post-market surveillance, and ongoing regulatory representative services (CH REP, UK RP, US Agent). The firm also sells two proprietary products: openQMS, a cloud-based electronic Quality Management System built on Atlassian Jira/Confluence, and confinis Academy, an e-learning platform delivering self-paced medical device compliance training.
Product overview
confinis is a global consulting firm specializing in regulatory affairs, quality management, and compliance services for medical devices, in vitro diagnostics, and combination products. The company's offerings include the confinis Academy (e-learning platform), openQMS (Atlassian-based electronic QMS), and comprehensive consulting services spanning regulatory affairs (CE marking, FDA registrations, EUDAMED/Swissdamed), quality management systems (ISO 13485, 21 CFR Part 820), cybersecurity, regulated AI, digital health, medical software/SaMD, combination products, clinical evaluation, and training. The portfolio is organized into three service categories: Regulatory, Compliance, and Beyond, providing end-to-end support from product development through market entry and post-market surveillance.
Differentiator
Problem solved
Functional benefit
Brands
- confinis Academy: A comprehensive e-learning platform tailored for the medical device industry, providing courses on regulatory affairs, quality management, EUDAMED, Swissdamed, AI in medical devices, and cybersecurity.
Products and services
- Regulatory Affairs Services Comprehensive regulatory strategy, CE marking, FDA registrations, EUDAMED/Swissdamed registration support, CH REP, UK REP, US Agent services, classification strategy, and global product registrations for medical device manufacturers.
- Quality Management System (QMS) Services Development and implementation of QMS tailored to EN ISO 13485 for global markets and 21 CFR Part 820 for US market, including gap analysis, implementation support, and certification facilitation.
- Combination Products Services Comprehensive regulatory affairs, quality management, design control, risk management, and post-market surveillance services for combination products including prefilled syringes, auto-injectors, pen-injectors, inhalers, stents, and drug-eluting patches.
- Cybersecurity Services Expert guidance on cybersecurity for medical devices including risk assessments, vulnerability analyses, SBOM management, penetration testing, incident response planning, and FDA/MDR compliance support.
- Regulated AI Services Consulting services for navigating regulatory challenges of AI-based medical devices, including AI risk management, validation, regulatory strategy development, and algorithm design guidance per FDA and EU requirements.
- Digital Health Services Strategic guidance for digital health solutions including mobile health apps, telemedicine services, wearable health technology, and broader digital health tools with regulatory compliance and market entry support.
- Medical Software and SaMD Services Expertise in software classification, SaMD regulatory navigation, IEC 62304-compliant software lifecycle management, cybersecurity integration, and documentation for medical device software.
- EUDAMED and Swissdamed Registration Services Registration support for EUDAMED (European Database on Medical Devices) and Swissdamed databases, guiding manufacturers through actor registration, UDI/device submissions, and compliance with MDR and IVDR requirements.
- confinis Academy E-learning platform delivering self-paced courses on regulatory and compliance topics for the medical device industry, including ISO 13485, EUDAMED, Swissdamed, AI in medical devices, cybersecurity, IEC 62304, clinical evaluation, FDA pathways, and QMSR.
- openQMS A paperless, cloud-based electronic Quality Management System developed in partnership with Atlassian (Jira and Confluence), providing fully customizable QMS documentation accessible via web browser with audit-readiness features.
Quantifiable outcome
- Successfully managed regulatory compliance for over 2,000 medical devices
- +1 more outcomes
Companies that use confinis
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles3 records
confinis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature3 records
confinis partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered notable and core.
- The Future of Health Grantnotableconfinis joined as Program Partner for The Future of Health Grant initiative. Provides regulatory expertise and mentorship support for healthcare innovation projects receiving grant funding.
- IrdetocorePartnership to launch the first cybersecurity assessment tool in the medical devices industry. Combined expertise to address growing cybersecurity concerns in medical device development and provide comprehensive security evaluation services.
- b-ray ZnotablePartnership concerning innovative Artificial Intelligence project in medical imaging/diagnostics. Collaboration to advance AI applications in breast cancer screening and regulatory compliance for AI-enabled medical devices.
Scale indicators3 records
Recent moves7 records
Expansion highlights6 records
confinis competitors and assessment
Company assessmentDirect peers
- RQM+: RQM+ is a U.S.-headquartered regulatory affairs and quality compliance consulting firm focused on medical devices and IVDs — the closest direct competitor to confinis in offering end-to-end FDA, EU MDR/IVDR, and quality system services to medtech manufacturers.
- MethodSense: MethodSense is a boutique life-science regulatory and quality consulting firm specializing in medical devices, IVDs, and combination products — directly comparable to confinis in scope (regulatory strategy, QMS, combination products) and target customer profile.
- Greenlight Guru: Greenlight Guru provides purpose-built eQMS software for the medical device industry, directly comparable to confinis' openQMS (Atlassian-based eQMS) offering, and to the e-learning/training arm in the medical device compliance space.
- ProductLife Group: ProductLife Group (formerly PharmaLex) is a global regulatory and compliance consulting firm serving medical device and pharmaceutical clients — overlapping with confinis in regulatory affairs, quality management, and combination product services across multiple jurisdictions.
- StarFish Medical: StarFish Medical is a medical device design and regulatory services firm serving startups through large medtech — comparable to confinis in addressing the startup/SME segment with integrated design control, regulatory strategy, and QMS implementation.
Broad incumbents
- ICON plc: ICON plc is a global CRO with a dedicated medical device and regulatory consulting arm; broader and more diversified than confinis but competes for enterprise med-device regulatory affairs engagements.
- TÜV SÜD: TÜV SÜD is a global Notified Body and testing/consulting organization that provides ISO 13485, MDR, and cybersecurity advisory for medical devices — competes with confinis in the med-device compliance consulting layer, though with deeper testing/auditing scope.
- NAMSA: NAMSA is a medical device-focused testing, regulatory, and quality consulting organization with global delivery — overlaps with confinis in regulatory affairs and QMS services but extends further into biological/laboratory testing.
- BSI Group: BSI Group is a global standards body and Notified Body providing ISO 13485 certification, MDR/IVDR conformity assessment, and related regulatory consulting — adjacent competitor to confinis with broader certification scope and deeper UK/EU presence.
Others
- BSI Clinical Services (RQM+ acquired by BSI): BSI's clinical and regulatory services combine certification body infrastructure with consulting — adjacent overlap with confinis for med-device manufacturers seeking integrated certification + consulting, particularly relevant given BSI's acquisition track record in this space.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
confinis social profiles
Digital presenceconfinis compliance and trust
Trust signalCompliance1 record
confinis financial estimates
Financial estimateRevenue estimate
Valuation estimate
confinis leadership team
Management profileNumber of profiles
Profiles5 records
confinis subsidiaries and ownership
Company hierarchySubsidiaries2 records
confinis funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
confinis 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 confinis
What does confinis do?
confinis provides regulatory affairs and quality management consulting services to medical device, in-vitro diagnostic, and combination product manufacturers, covering the full product lifecycle from regulatory strategy and CE/FDA market authorization through QMS implementation, clinical evaluation, post-market surveillance, and ongoing regulatory representative services (CH REP, UK RP, US Agent). The firm also sells two proprietary products: openQMS, a cloud-based electronic Quality Management System built on Atlassian Jira/Confluence, and confinis Academy, an e-learning platform delivering self-paced medical device compliance training.
Is confinis a public or private company?
confinis is a private company. It is classified as management employee owned and is currently operating.
When was confinis founded?
confinis was founded in 2005. It employs 11 to 50 people.
Where is confinis based?
confinis is headquartered in Düdingen, Switzerland, in the Europe region.
How does confinis make money?
Two revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are training and Education.
Who are confinis's main competitors?
Direct peers on record are RQM+, MethodSense, Greenlight Guru, ProductLife Group and StarFish Medical. Broad incumbents are ICON plc, TÜV SÜD, NAMSA and BSI Group. BSI Clinical Services (RQM+ acquired by BSI) is listed as an others.
Does confinis have an API?
No public API is recorded for confinis.
What industry is confinis in?
confinis'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). Its NAICS code is 541690 and its SIC code is 8731.