Congenius AG

What Congenius AG does

Congenius AG is a privately held Swiss medical technology consultancy founded in 2016 and headquartered in Dietikon, Switzerland. The firm provides tailored consulting across five integrated excellence areas — Quality, Regulatory, eHealth, Operations, and Clinical — to global MedTech firms, established SMEs, and MedTech start-ups. Its core product is QMgeniuS, an MDR- and IVDR-compliant QMS/eQMS solution specifically designed for start-ups, delivered either as a digital document management system (built on the Simploud backbone and SharePoint) or as a paper-based QMS, validated per ISO 13485, EU MDR/IVDR, and 21 CFR Part 11. Congenius states 70 employees with an average of 15 years of MedTech industry experience per consultant, a customer base of 250, and 680 completed projects over its 10-year history.

The company monetizes primarily through professional-services engagements (project-based and retainer consulting) supplemented by an annual subscription licence for the QMgeniuS digital eQMS and paid Academy events. GTM is consultative enterprise sales driven through website demo requests, the free MinigeniuS advisory service, and Academy webinars in partnership with Health Tech Cluster Switzerland, Swiss Healthcare Startups, Sitem StartUp Club, and USI. Distribution is direct and global (Switzerland, D-A-CH, US, Canada, China, Japan), with no disclosed channel partner or reseller network.

Congenius is founder-influenced: Jörg Dogwiler founded the firm and remains President of the Board and lead of business development, while Bastian Perroset became CEO in 2024. The Board includes senior former executives from Roche, Biotronik, Philips, Ypsomed, Zimmer Biomet, and Hocoma. The firm remains privately held with no disclosed external investors, funding rounds, M&A activity, or subsidiaries.

Name

Congenius AG

Legal name

Congenius AG

Website

https://congenius.ch

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Congenius AG is a Swiss MedTech consultancy founded in 2016 providing tailored Quality, Regulatory, eHealth, Operations, and Clinical consulting to MedTech start-ups, SMEs, and global firms, plus the QMgeniuS eQMS product.

Ownership category

akta.pro rank

Product category

Medical Device Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Computer Systems Design Services (541512)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL), Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ), Instrumentation, Controls & Automation Engineering Consulting (BPAHAIAM)

Keywords

• Medical device consulting
• Regulatory affairs services
• Quality management systems
• EHealth consulting
• Clinical affairs services

Headquarters

HQ city

Zürich

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Medical Device Consulting Services: Congenius provides tailored consulting across five excellence areas: Quality, Regulatory, eHealth, Operations, and Clinical. Projects span QMS setup, regulatory strategy, technical documentation, software lifecycle management, process validation, and clinical evaluation. Revenue is generated through billable consulting engagements scoped to each customer requirement.
2. QMgeniuS eQMS Annual Licence: The digital QMgeniuS eQMS is offered on an annual licence fee model. The licence includes full support and change requests. This represents a recurring subscription revenue stream from the QMS product targeted at start-ups.
3. QMgeniuS Paper-Based QMS Consulting: For customers preferring a paper-based QMS solution, Congenius charges a consultant fee for tailoring processes and implementing them according to the customer's needs. This is a one-time consulting fee model.
4. Congenius Academy Training & Events: Congenius Academy delivers webinars, talks, training sessions, Q&As, and collaborative learning events across topics such as ISO 10993 biocompatibility, MDR/IVDR regulatory affairs, AI/ML in medical devices, reimbursement strategy, and design controls. Some events are free (e.g., HTCS Regulatory Q&As), others are paid. Revenue is generated through event registration fees and sponsored sessions.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Congenius AG is a Swiss medical technology consultancy that provides specialized consulting services across Quality, Regulatory, eHealth, Operations, and Clinical functions for medical device, in-vitro diagnostic (IVD), and pharmaceutical companies. The firm also offers QMgeniuS, a proprietary QMS/eQMS software solution designed specifically for MedTech start-ups to manage quality and regulatory documentation. Headquartered in Dietikon, Switzerland and founded in 2016, the company has 70 employees averaging 15 years of MedTech experience.

Product overview

Congenius AG is a Swiss medical technology consultancy offering a portfolio of specialized services across five excellence areas: Quality, Regulatory, eHealth, Operations, and Clinical. Their primary product is QMgeniuS, an MDR & IVDR compliant QMS/eQMS solution specifically designed for MedTech start-ups, delivered either as a digital Document Management System (DMS) or via paper-based execution. Complementing this core software product, they provide comprehensive consulting services spanning quality management systems, regulatory affairs strategy and submissions, medical device software (SaMD/SiMD) development support, manufacturing operations optimization, and clinical affairs including evaluation and investigations. The portfolio is unified by their focus on helping MedTech companies achieve regulatory compliance and market access.

Differentiator

Problem solved

Functional benefit

Brands

• QMgeniuS: An MDR & IVDR compliant QMS / eQMS solution tailored for start-ups, offering flexible implementation to save time and money. It provides a basic framework for establishing a complete QMS according to ISO 13485.

Products and services

• Quality Management Consulting

Quantifiable outcome

• 680 successful projects completed across 10 years of existence
• +3 more outcomes

Named customers11 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature2 records

Partnerships

14 partnerships are on record, tiered minor and core.

• Swiss MedTechminorOthersSwiss MedTech is the association of Swiss medical technology, representing more than 600 companies. Founded in 2017, it represents and promotes the interests of the Swiss medical technology industry. Congenius is a member, enabling industry representation and networking.
• MedTech & Pharma Platform AssociationminorOthersThe MedTech & Pharma Platform (MPP) connects companies from pharma, MedTech, and tech sectors to exchange knowledge and collaborate on technology and regulatory areas for combined products. Congenius participates as a member, supporting industry dialogue and combined-product expertise.
• SNV — Swiss Association for StandardizationminorOthersSNV is the Swiss representative for global and European standardization, serving as a bridge between standardization experts and those using the standards. By partnering with SNV, Congenius joins a worldwide standardization network and shapes technical framework conditions in the MedTech industry.
• Health Tech Park Zurich-SchlierencoreGTM or Marketing PartnerHealth Tech Park Zurich-Schlieren supports Health Tech start-ups in developing companies and gaining market access. Congenius is an Official Service Partner for Quality, Regulatory Affairs, and Digital Health. The partnership aligns with Congenius's mission to support MedTech start-ups and provides a referral channel for consulting engagements.
• Swiss Healthcare StartupscoreGTM or Marketing PartnerSwiss Healthcare Startups is a non-profit organisation supporting innovative startups in the Swiss healthcare ecosystem since 2016. It provides CORTEX digital directory, partner network, and event access. Congenius collaborates on Academy events (e.g., Biocompatibility webinar) and provides expert knowledge to the startup community.
• Sitem StartUp ClubcoreGTM or Marketing PartnerThe Sitem StartUp Club (SSC), founded by sitem-insel AG, UniBE, and Insel Group in 2020, supports MedTech startups with coworking space, networking, and the MedTech Booster (MTB) acceleration program. Congenius collaborates with SSC to help develop MedTech startups into thriving businesses through workshops and consulting.
• KAPSLYminorGTM or Marketing PartnerKAPSLY enables HealthTech founders to launch successful companies faster through a network of service partners, corporates, and investors. Congenius is partnered with KAPSLY as a sponsor, helping reduce operational risks and accelerate time-to-market for HealthTech start-ups.
• BluelionminorGTM or Marketing PartnerBluelion is a Zurich-based startup incubator and non-profit organisation helping tech entrepreneurs get from 0 to 1. Congenius shares its team's expertise as one of Bluelion's experts, supporting the incubator's community of entrepreneurs.
• Zurich Chamber of CommerceminorGTM or Marketing PartnerFounded in 1873, the Zurich Chamber of Commerce represents approximately 1,100 member companies in cantons Zurich, Schaffhausen, and Zug. Congenius is a member, benefiting from industry representation, networking, and business development opportunities.
• USI Università della Svizzera italianacoreStrategic or Co-development PartnerUSI is one of 12 certified public universities in Switzerland. Congenius collaborates in the creation of the eHealth Business Program — a learning program providing entrepreneurs with knowledge and skills to establish a strong position in the market and prepare for eHealth start-up growth.
• Wyss ZurichminorStrategic or Co-development PartnerWyss Zurich Translational Center fosters translational projects from ETH Zurich and the University of Zurich in regenerative medicine, robotics, and medical devices/bionics. Congenius contributes expertise to support entrepreneurship and translation of science into life improvements.
• SimploudcoreImplementation/ SI/ Consulting PartnerSimploud is a digital partner that provides the digital backbone for Congenius's QMgeniuS e-solution. Together they deliver a lean QMS that is MDR, IVDR, and 21 CFR Part 11 compliant, specifically designed for the dynamic environment of medical device companies.
• Swiss m4m CenterminorImplementation/ SI/ Consulting PartnerSwiss m4m Center is a leading company in additive manufacturing within the medical device industry, with ISO 13485-certified infrastructure. Congenius partners with m4m to provide comprehensive quality and regulatory support for companies adopting additive manufacturing for innovative medical devices.
• MArS — Market Access & Pricing StrategycoreImplementation/ SI/ Consulting PartnerMArS specialises in market access strategies and implementation within the D-A-CH region (Germany, Austria, Switzerland), the US, and Canada. Services include reimbursement dossiers, consultation procedures, pricing negotiation with health authorities and insurance providers, health economics modelling, and stakeholder engagement. Congenius partners with MArS to provide enhanced reimbursement strategy solutions for start-up and established medical device companies.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• NAMSA: Global MedTech-focused CRO and regulatory/quality consultancy spanning testing, clinical research, and regulatory strategy. Comparable in offering breadth across the five-pillar service model Congenius provides.
• Qualio: Cloud-native eQMS purpose-built for life sciences start-ups and scale-ups. Competes directly with QMgeniuS in the MedTech start-up QMS market Congenius targets.
• Greenlight Guru: MedTech-focused eQMS platform with built-in regulatory workflows and consulting partnerships. Closest competitor to Congenius's QMgeniuS product line and a direct alternative for the start-up QMS customer segment.
• Qserve Group: Dutch-headquartered MedTech regulatory, quality, and clinical consultancy offering similar services across EU MDR/IVDR, ISO 13485, FDA, and clinical evaluation. Most directly comparable competitor in size, scope, and customer base to Congenius.
• Medidee Services: Swiss-headquartered MedTech regulatory, quality, and clinical affairs consultancy. Highly comparable as a near-identical geographic and service competitor within the Swiss MedTech ecosystem.

Broad incumbents

• ICON plc: Large global CRO and clinical/regulatory services provider. Comparable on the Clinical pillar of Congenius's offering, particularly clinical investigations and medical writing for MedTech.
• MasterControl: Established life-sciences eQMS and quality management software vendor with broader enterprise footprint than QMgeniuS. Comparable as an alternative QMS platform for Congenius's regulated device clients.
• TÜV SÜD: Global testing, inspection, certification, and training organisation active across MedDevice regulatory and quality. Comparable as a large-scale incumbent Congenius competes against on enterprise certification and consulting mandates.
• BSI Group: Global standards body and certification/consulting organisation that issues ISO 13485 certification and runs MedTech training and consultancy programmes. Comparable as a larger, broader-scope incumbent in the same quality and regulatory compliance space.

Emerging players

• ETQ (Hexagon): Quality management software vendor with growing MedTech/life-sciences presence. Competes with QMgeniuS as an alternative eQMS for the same regulated customer base.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/congenius-ag
• Xx.com/CongeniusAG

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Congenius AG