What consys does

Consys AG is a privately held Swiss software and consulting company headquartered at Technopark Winterthur (Technoparkstrasse 2, 8406 Winterthur), specializing in electronic Quality Management Systems (eQMS) for regulated industries with a primary focus on medical technology. The core product is a web-based eQMS platform composed of ten integrated modules covering process and document management, training management, error/CAPA management, improvement suggestions, change control with risk assessment, goal management, opportunity/risk management, audit management, contract management, and equipment management — supporting compliance with ISO 13485, EU MDR, FDA 21 CFR Part 820, ISO 14971, and other regulated-industry standards through features such as audit trails and electronic signatures.

The company operates a sales-led, consulting-overlay commercial model. Revenue is generated through three streams: subscription-based access to the eQMS platform, professional-services consulting for QM and regulatory affairs (offered both bundled with software and independently), and tiered implementation packages — Basic, Professional, and 360 — that combine software with progressively deeper implementation, normalization, and long-term support services on multi-year contracts. Pricing is not publicly disclosed and is engaged via direct contact rather than self-serve. Go-to-market is direct, with personalized software demos and case-study-led content marketing supported by LinkedIn and a German-language website. Target customers span MedTech manufacturers, CH-REPs/importers/distributors, MedTech suppliers, healthcare providers (hospitals, clinics, psychiatric institutions, elderly care), government and municipal customers, and selected general-industrial firms — a base exceeding 100 customers in regulated industries across German-speaking markets, primarily Switzerland with secondary reach into Germany.

Founded in 2001 as a spin-off from Werren & Thomann GmbH, Consys has evolved through a 2005 technology partnership with AAC Infotray AG (Limsophy BPM), a 2010 integration of Scheuring Vertrieb Schweiz GmbH, a 2017 strategic partnership with Pragmatec Consulting GmbH, and a 2024 merger that absorbed Pragmatec's consulting practice into Consys AG. The company was acquired by current Managing Director Serdar Gelebek in 2023 and operates today with a small internal team of 1–10 employees supplemented by an external expert network. Multiple regulatory and quality certifications are supported by the platform, including ISO 13485, ISO 9001, ISO 14971, EU MDR, FDA 21 CFR Part 11, and GDPR/DSG-compliant data processing.

Name

consys

Legal name

Consys AG

Website

https://consys.ch

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

1–10 employees

Short description

Consys AG is a privately held Swiss firm providing a modular web-based eQMS platform and regulatory consulting services — covering ISO 13485, EU MDR, FDA, and related standards — to MedTech companies, healthcare providers, and other regulated organizations across German-speaking markets.

Ownership category

akta.pro rank

Product category

Electronic Quality Management Systems (eQMS)

NAICS

Software Publishers (5132), Software Publishers (51321), Custom Computer Programming Services (541511), Computer Systems Design Services (541512)

SIC

Services-Prepackaged Software (7372), Services-Computer Programming, Data Processing, Etc. (7370), Services-Management Consulting Services (8742)

akta.pro primary industry

ESG, Sustainability Reporting & Compliance (BPAEAPAM)

akta.pro secondary industries

Records Management, Information Governance & Retention (BPAEAPAO), Sustainability & ESG Consulting (BPAHACAK)

Keywords

• Quality management software
• Regulatory compliance consulting
• Electronic QMS platform
• MedTech quality systems
• ISO 13485 compliance

Headquarters

HQ city

Pfaffikon

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. QM Software (eQMS): Subscription-based access to the proprietary web-based Quality Management System. Includes software modules for document management, process management, complaint handling, audit management, risk management, training management, contract management, and equipment management.
2. Consulting Services: Advisory services for Quality Management, Regulatory Affairs (including PRRC), and process digitization. Offered independently or bundled with software packages. Includes ISO implementation support, MDR/FDA compliance consulting, internal audits, supplier audits, and interim QM management.
3. Implementation Packages: Three structured service packages (Basic, Professional, 360) combining software and consulting support at different intensity levels for QMS implementation and ongoing development.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Consys AG develops and sells a proprietary web-based electronic Quality Management System (eQMS) for regulated industries, complemented by regulatory and quality management consulting services. The platform centralizes processes, documents, training, complaints/CAPA, audits, risks, contracts, and equipment with electronic signatures and full audit trails to support ISO 13485, EU MDR, and FDA 21 CFR Part 11 compliance. Customers access the software through subscription packages (Basic, Professional, 360) and can also engage Consys independently for ISO implementation, MDR/FDA consulting, audits, and interim QM management.

Product overview

Consys offers a modular electronic Quality Management System (eQMS) called QM-Software, comprising ten integrated modules: Prozess- und Dokumentmanagement, Weiterbildungsmanagement, Fehlermanagement, Verbesserungsmeldungen, Änderungen, Zielmanagement, Chancen und Risiken, Auditmanagement, Vertragsmanagement, and Betriebsmittelmanagement. The software is delivered through three implementation packages—Basic (Digital Foundation), Professional (Norm-compliant QMS), and 360 (Full-Service Support)—offered alongside consulting services for quality management, regulatory affairs, and business processes. The company also provides Rundumbetreuung (full-service care) combining software, consulting, training, and ongoing development. The portfolio is complemented by PRRC support services for MedTech companies.

Differentiator

Problem solved

Functional benefit

Products and services

• QM-Software (eQMS) Web-based electronic Quality Management System (eQMS) that centrally manages processes, documents, responsibilities, and evidence. Provides audit trail, electronic signatures, and compliance with ISO 13485, MDR, and FDA 21 CFR Part 11 for MedTech and other regulated companies.
• Beratung (Consulting) Advisory services covering quality management, regulatory affairs, and business processes, including ISO 9001 and ISO 13485 management system setup, interim QM management, PRRC support, risk analysis, qualification and validation, medical device product approval, and internal/supplier audits. Available independently of the software.
• Rundumbetreuung (Full-Service Support) Full-service quality management care combining consulting, software, training, and ongoing development for customers with limited QM resources. Provides a holistic solution from initial implementation through long-term support, integrating regulatory expertise with continuous digital system management.

Quantifiable outcome

• Significant reduction in time spent searching for current documents
• +3 more outcomes

Named customers28 records

Segments7 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature12 records

Partnerships

Two partnerships are on record, tiered core and minor.

• Pragmatec Consulting GmbHcoreStrategic or Co-development Partner · 1 January 2024Strategic fusion completed in 2024 where Pragmatec Consulting GmbH's consulting services were taken over by Consys AG. This fusion expanded Consys' service portfolio to include: management system setup and optimization (ISO 9001, ISO 13485), interim/external QM management, external project management, moderation of product and process risk analysis, qualification & validation, medical device product approval, internal and supplier audits, workshop moderation for process analysis, reorganization support, and digitization of existing processes.
• Pragmatec Consulting GmbHminorStrategic or Co-development Partner · 1 January 2017Strategic partnership formed in 2017 with Pragmatec Consulting GmbH, enabling both companies to combine resources and know-how to offer more comprehensive and efficient solutions to customers.

Scale indicators3 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Dot Compliance: AI-enabled eQMS solution for life sciences and MedTech, covering document, change, training and audit management on Salesforce. Competes in the same MedTech QMS software category Consys addresses, with stronger automation/AI marketing but overlapping regulatory focus.
• ComplianceQuest: Cloud QMS built natively on Salesforce for regulated manufacturers, including MedTech, with document, CAPA, audit and risk modules. Closely comparable enterprise-grade eQMS competitor, though at a different scale than Consys.
• SimplerQMS: eQMS software targeting medical device and life sciences manufacturers with validation-ready document, training and change control modules. Comparable in scope and customer profile to Consys' modular eQMS for regulated MedTech firms.
• Greenlight Guru: eQMS platform designed specifically for medical device companies, with modules for design controls, risk management, CAPA and audit management. Direct competitor to Consys' regulated-industry QMS offering, particularly in the MedTech CH-REP and manufacturer segments.
• Qualio: Cloud-based eQMS purpose-built for life sciences and MedTech companies, offering document, training, complaint and audit management. Closely comparable to Consys' web-based eQMS with similar ISO 13485 and FDA 21 CFR Part 11 orientation, though at larger scale and broader geographic reach.

Broad incumbents

• Sparta Systems (TrackWise): Long-standing TrackWise QMS platform serving life sciences and MedTech with enterprise-grade quality, complaint and CAPA workflows. A broader incumbent competing for the larger end of the regulated MedTech segment Consys targets.
• Ideagen: Provider of governance, risk and compliance software including QMS offerings for regulated industries such as life sciences and healthcare. Comparable in regulated-industry QMS focus and serves some of the same buyer personas as Consys.
• MasterControl: Established enterprise QMS platform serving life sciences and other regulated industries with document, training, CAPA and audit management plus services. A much larger incumbent that competes across multiple of Consys' target segments, including MedTech.
• Veeva Systems (Vault QMS): Major life sciences cloud platform with Vault QMS covering quality, manufacturing and regulatory processes. A broad incumbent in regulated-industry QMS that competes for larger MedTech accounts and sets benchmark expectations Consys must meet.
• EtQ: Quality management software provider with broad coverage of document control, CAPA, audits and risk, serving regulated manufacturers including MedTech. A broader incumbent that overlaps with Consys on quality and compliance workflows for regulated companies.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/consysag

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

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 consys