BAYOONET

What BAYOONET does

BAYOONET Group is a privately held German technology group founded in 2001, operating under the BAYOONET AG holding with approximately 300 employees ('Mitdenker:innen') across eight DACH locations (Darmstadt HQ, Berlin, Munich, Cologne, Ludwigsburg, Höhn, Mannheim, and Basel). The group comprises roughly twelve specialized entities covering medical software development (BAYOOMED), regulatory affairs and legal manufacturer services (BAYOOCARE, BAYOOCARE Swiss), enterprise software for regulated industries (BAYOOTEC), proprietary management software (BAYOOSOFT — Risk Manager, Access Manager, Themis, gpg4o, AMPR), medical device hardware manufacturing (Mechatronic Medical Engineers), product design (Puls), and UX/UI (UID), with all capabilities consolidated under the YOOme brand for the MedTech segment. The company has over 25 years of operating history, 150+ completed digital health projects at BAYOOMED, and holds market authorization in 30+ countries via MDSAP, ISO 13485, ISO 27001, EU MDR QMS, and related certifications.

BAYOONET's core technology stack spans medical device software across all IEC 62304 safety classes, embedded, mobile, web, and cloud development using Java, C#, .NET, PHP, Vue.js, TypeScript, Angular, React, Swift, Kotlin, Xamarin, and React Native, alongside the proprietary MedicalOne Connect healthcare platform and the BAYOOSOFT suite for identity and access management, risk management, and technical documentation. The group combines software engineering, regulatory consulting, UX/UI design, and physical product manufacturing under one roof. The group's primary technology differentiators are regulatory certifications, legal manufacturer status (BAYOOCARE), and the breadth of capabilities that allow customers to move from ideation through software development, regulatory submission, and physical device production without switching vendors.

BAYOONET generates revenue through four streams: (1) custom professional services for medical software, enterprise software, IT security, and product design billed on a project basis; (2) software product licenses and subscriptions for the BAYOOSOFT suite sold directly to regulated enterprises and KRITIS operators; (3) hardware sales of physical medical and IVD products manufactured at the Mechatronic facility; and (4) regulatory affairs and legal manufacturer consulting services. The company sells exclusively through direct enterprise field sales and inside sales across all entities, with no reseller or marketplace channel presence. Customers are concentrated in MedTech, Pharma, KRITIS/Energy, and Industrial segments, with named reference customers including OCULUS Optikgeräte, Kulzer, biotrics, SCHMITZ medical, PAUL HARTMANN, and TNI Medical. Pricing is quote-based and not publicly disclosed.

Name

BAYOONET

Legal name

BAYOONET Service GmbH & Co. KG

Website

https://bayoo.net

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

101–250 employees

Short description

BAYOONET Group is a German technology group of ~12 companies serving regulated industries (MedTech, Pharma, KRITIS, Energy) with medical software development, regulatory affairs, IT security software, and physical medical device manufacturing across eight DACH locations.

Ownership category

akta.pro rank

Product category

Medical Technology Software & Regulatory Services

NAICS

Computer Systems Design and Related Services (54151), Software Publishers (5132)

akta.pro primary industry

DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)

akta.pro secondary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Medical device software
• Regulatory affairs consulting
• Identity access management
• Medical device manufacturing
• Regulated enterprise software

Headquarters

HQ city

Darmstadt

HQ country

Germany

HQ region

Europe

Offices8 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Custom Software Development Services: BAYOONET Group provides bespoke software development for regulated industries (MedTech, Pharma, IT Security, Energy, KRITIS, Industrial). Services include software development in all IEC 62304 safety classes, UX/UI design, regulatory affairs consulting, and product design. Revenue is generated through project-based professional services engagements with enterprise clients.
2. Software Product Licenses (BAYOOSOFT Suite): BAYOOSOFT sells standardized software products (Risk Manager, Access Manager, gpg4o, Themis) to regulated industries and critical infrastructure operators. Products likely follow subscription or perpetual license models, with B2B sales through account executives and presales consultants.
3. Medical Device Manufacturing (Mechatronic): Mechatronic Medical Engineers GmbH manufactures physical medical and in-vitro diagnostic products at the group's own production facility, including life-supporting devices. Revenue generated from physical product sales.
4. Regulatory Affairs & Consulting (BAYOOCARE): BAYOOCARE provides regulatory compliance consulting, market authorization services, and legal manufacturer status for medical device and IVD companies. Services span the product lifecycle including post-market surveillance and clinical trial support.

Go-to-market motion3 records

Distribution channels1 record

Marketing channels6 records

Core offering

BAYOONET Group is a B2B technology group that delivers custom software development, proprietary software products, regulatory affairs consulting, and physical medical device manufacturing to regulated industries. Its subsidiaries develop IEC 62304-compliant medical software, identity & access management and IT security solutions (BAYOOSOFT Risk Manager, Access Manager, Themis, gpg4o), enterprise software for KRITIS/energy sectors, and manufacture physical medical devices (ventilators, IVD products). The group also serves as a legal manufacturer holding MDR, ISO 13485, MDSAP, and ISO 27001 certifications, enabling international market authorization in 30+ countries.

Product overview

BAYOONET Group is a technology conglomerate comprising 12 specialized companies operating in software development, IT security, medical technology, and UX/product design. The portfolio includes BAYOOCARE (regulatory affairs/legal manufacturing), BAYOOMED (medical software including DiGA, DTx, embedded, web and cloud solutions), BAYOOTEC (customized enterprise software for regulated industries), BAYYOOSOFT (management software including Risk Manager, Access Manager, Themis, and gpg4o email encryption), YOOme (comprehensive medical device development brand), and specialized units for hardware manufacturing (Mechatronic), product design (Puls), and UX/UI (UID). The group serves regulated industries including MedTech, pharma, energy/KRITIS, and telecommunications.

Differentiator

Problem solved

Functional benefit

Brands

• BAYOOCARE: Regulatory Affairs and Legal Manufacturer services for medical devices and IVD products
• BAYOOMED
• BAYOOSOFT
• BAYOOTEC
• Mechatronic
• Puls
• UID
• YOOme

Products and services

• BAYOOCARE Regulatory Affairs & Legal Manufacturer Service Regulatory affairs consultancy and legal manufacturer service for medical devices and IVD products. Provides strategic advice on international compliance, quality management, post-market surveillance, and MDSAP certification support for MedTech and pharma companies.
• BAYOOMED Medical Software Development Services ISO 13485-certified software development services for digital health, medical software, embedded systems, mobile apps (DiGA, DTx, Companion Apps), web, cloud, and desktop solutions for pharma, MedTech, health insurers, and life sciences. Includes MedicalOne Connect platform.
• BAYOOSOFT Risk Manager Risk management software for regulated industries and medical devices, enabling risk analyses and software FMEAs in accordance with ISO 14971.
• BAYOOSOFT Access Manager Identity and access management software for enterprise IT environments, enabling permission management, temporary delegation rights, and audit-compliant access control.
• BAYOOSOFT Themis Technical Documentation Platform Cloud-based technical documentation platform for MDR/IVDR-compliant documentation creation and QMS/ISMS management systems for medical devices and IVD products.
• gpg4o Email Encryption (Outlook Add-in) End-to-end email encryption Outlook plugin for particularly sensitive environments, enabling secure email communication with easy implementation.
• BAYOOTEC Enterprise Software Development Services Customized enterprise software development services for regulated industries including KRITIS, energy sector, renewable energies, telecommunications, and industrial environments.
• Mechatronic Medical Engineers (MME) Hardware Manufacturing Hardware development and manufacturing services for physical medical and IVD products including ventilators and life-supporting devices, with over 30 years of manufacturing experience in Germany.
• YOOme Medical Device Development Comprehensive medical device development brand covering medical and pharmaceutical software development, international product approval, product design, and physical medical and IVD product development under one umbrella.
• Puls Produktdesign Services Industrial and product design services for medical devices and consumer products.
• UID UX/UI Design Services User experience and user interface design services, including UX research, HMI design, and interactive system prototyping.

Quantifiable outcome

• Market authorization in over 30 countries through MDR, IVDR, and MDSAP certifications
• +3 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature7 records

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Zühlke Group: Swiss-headquartered technology and engineering services firm with deep MedTech and regulated industries focus. Closely comparable to BAYOONET's BAYOOMED and BAYOOTEC offerings, with similar IEC 62304, MDR, and ISO 13485 capability stack.
• MasterControl: Provider of quality management and regulatory compliance software for life sciences and MedTech. Direct competitor to BAYOOSOFT's Risk Manager and Themis products in the medical device QMS space.
• Greenlight Guru: Specialized QMS and design controls software for medical device companies. Competes directly with BAYOOSOFT Risk Manager for ISO 13485 and ISO 14971 workflows in mid-market MedTech.
• Nagarro: Global digital engineering services firm with a strong life sciences and healthcare vertical. Competes with BAYOOMED and BAYOOTEC for custom medical software development and regulated enterprise software projects.
• Reply Group: European IT services and consulting group with vertical practices in healthcare, energy, and regulated industries. Direct comparable on enterprise software development for KRITIS and energy sector clients.
• Allgeier: German-headquartered IT services group with strong presence in regulated industries (energy, public sector). Comparable to BAYOONET's BAYOOTEC and BAYOOSOFT offerings in the German Mittelstand market.

Broad incumbents

• Capgemini Engineering: Engineering and R&D services arm of Capgemini, including extensive MedTech and life sciences capabilities. A much larger incumbent competing for the same enterprise MedTech software and regulatory projects.
• TÜV SÜD: Global testing, inspection, and certification body with growing MedTech and digital health service lines. Competes with BAYOOCARE on regulatory affairs, certification support, and quality management consulting.
• Polarion (Siemens): Application lifecycle management and traceability platform widely used in medical device software development. Competes indirectly with BAYOOSOFT's documentation/Themis capabilities within IEC 62304 workflows.

Regional players

• GFT Technologies: German IT services and digital transformation provider with financial services and regulated industries focus. Compares to BAYOOTEC on enterprise software and IT security for European clients.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance14 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries10 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 BAYOONET