Bayoomed

What Bayoomed does

Bayoomed (BAYOOMED GmbH) is a German digital-health company headquartered in Darmstadt and operating as a subsidiary of BAYOONET AG under the YOOme network of five specialized subsidiaries. The company develops regulatory-grade medical software and applications for pharmaceutical companies, medical device manufacturers, life science organizations, and German statutory health insurers (Krankenkassen). Its delivery scope spans the full medical software lifecycle — requirements engineering, architecture design under IEC 62304, implementation, verification and validation, clinical evaluation, risk management, usability/human factors, technical documentation, market launch, and post-market surveillance — supported by ISO 13485 certification and MDSAP compliance audited by TÜV Hessen.

The underlying technology stack spans C#, Java, HTML5, C/C++, JavaScript, MAUI, React Native, and Flutter across web/cloud, embedded, mobile, and connected medical-device environments, with cybersecurity services aligned to IEC 81001-5-1 and AAMI TR57. The proprietary MedicalOne Connect platform acts as the integration backbone for DiGA (Digitale Gesundheitsanwendungen), DTx (Digital Therapeutics), Standard Digital Health Technologies, and Digital Clinical Trial solutions, with modular packages covering HealthID integration, electronic patient record (ePA) connection, MIO interoperability mapping, BSI TR-03161 code validation, and DiGA invoice/billing processing. The platform is GDPR-compliant and supports BSI-certified DiGA deployment.

Bayoomed operates a hybrid revenue model combining project-based professional services on multi-year enterprise contracts with subscription/recurring fees for MedicalOne Connect platform packages. Customer acquisition is driven by direct enterprise sales supported by content marketing, SEO, industry events, and targeted B2B outreach (including Apollo.io for lead identification). Named enterprise customers span major pharma (Boehringer Ingelheim, Bayer, Roche, Merck, Daiichi Sankyo, Ferring, Ipsen, Santen, Merz Therapeutics, allergopharma), MedTech (Ottobock, Dräger, Biotronik, YPSOMED, Burmeier, Stiegelmeyer, ERBE, CompuGroup Medical, cimon medical, Eyeseetec, Sonion, Berlin-Chemie Menarini), Life Science (r-biopharm, QuantBio, ROX – TIB Molbiol, Sightandlife, BAG Diagnostics, Vectura), and health insurance (DAK Gesundheit, BIG, plus DiGA-delivered products such as 'Meine Tinnitus-App' for Infectopharm and Kaia Health). The company operates from seven locations — Darmstadt (HQ), Munich, Berlin, Cologne, Ludwigsburg, and Höhn in Germany, plus Basel in Switzerland — supporting a workforce of 51–100 employees.

Name

Bayoomed

Legal name

BAYOOMED GmbH

Website

https://bayoomed.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

51–100 employees

Short description

Bayoomed (BAYOOMED GmbH) is a Darmstadt-based German digital-health company that develops regulatory-grade medical software, DiGA/DTx solutions, and the MedicalOne Connect platform for pharmaceutical, medical device, life science, and health-insurance clients across Germany and Switzerland.

Ownership category

akta.pro rank

Product category

Medical Software Development

NAICS

Custom Computer Programming Services (541511), Software Publishers (51321), Computer Systems Design and Related Services (5415)

SIC

Services-Computer Programming Services (7371), Services-Prepackaged Software (7372), Services-Health Services (8000)

akta.pro primary industry

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

akta.pro secondary industries

Medical Device & IoT Security (Connected Devices/RPM/OT) (HLACAJAI), SaMD – Monitoring, Triage & Risk Stratification Software (HLACANAE), Medical-Grade Device Connectivity & Device Management (MDM) (HLACAFAG), Revenue Cycle, Coding & Telehealth Compliance Platforms (for provider orgs) (HLALABAM)

Keywords

• Medical software development
• Digital health applications
• DiGA development services
• Regulatory compliance consulting
• Medical device software

Headquarters

HQ city

Darmstadt

HQ country

Germany

HQ region

Europe

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Custom Software Development Services: Project-based medical software development for pharma and MedTech companies, including medical apps, companion apps, embedded software, connectivity solutions, cloud solutions, AI integration, and digital biomarkers. Services span from consultation through development to post-market surveillance.
2. DiGA/DTx Platform & Packages: MedicalOne Connect platform providing pre-configured packages for DiGA (Digital Health Applications) including app and backend packages, backend-only packages, services packages (HealthID integration, ePA connection, MIO mapping, validation, invoice processing), DTx packages, and Standard DHT packages.
3. Regulatory & Consulting Services: Expert services including QMS, ISMS, clinical evaluation, risk management, usability/HFE, technical documentation, and micro consulting for medical device compliance (MDR, FDA, BSI).

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Bayoomed develops regulated medical software and operates the MedicalOne Connect platform, delivering custom medical apps, DiGA/DTx products, connectivity, embedded software, cloud solutions, AI/LLM features, and digital biomarkers for pharmaceutical, MedTech, life science, and health-insurance customers. The company combines project-based medical software development with pre-configured platform packages (DiGA App & Backend, DiGA Backend, DiGA Services, DTx App & Backend, Standard DHT) and end-to-end regulatory services spanning QMS, ISMS, clinical evaluation, risk management, usability, cybersecurity, technical documentation, market launch, and post-market surveillance under IEC 62304, MDR, FDA, and BSI TR-03161 frameworks.

Product overview

Bayoomed is a digital health services company offering custom medical software development, regulatory consulting, and the MedicalOne Connect healthcare platform. The MedicalOne Connect platform serves as the core infrastructure supporting a modular product family: the Digital Clinical Trial Platform module for digitized clinical research; the DiGA App und Backend Paket and DiGA Backend Paket for digital health application deployment; the DiGA Services Paket covering HealthID integration, ePA connection, MIO interoperability mapping, code validation, and invoice processing; the DTx App und Backend Paket for digital therapeutics; and the Standard DHT Paket for general Digital Health Technology. Development services include medical apps, connectivity, cloud solutions, embedded software, AI, digital biomarkers, companion apps, cybersecurity, QMS, ISMS, clinical evaluation, risk management, usability engineering, technical documentation, micro consulting, market launch, and post-market surveillance — all aligned with IEC 62304, EN ISO 14971, IEC 62366, and IEC 81001-5-1 standards.

Differentiator

Problem solved

Functional benefit

Brands

• MedicalOne Connect: Healthcare platform for digital health applications, DiGA, DTx, and digital clinical trials
• YOOme

Products and services

• MedicalOne Connect Flagship GDPR-compliant healthcare platform by Bayoomed that connects medical technologies, healthcare professionals, and patients in a secure, cost-efficient manner, providing the infrastructure backbone for DiGA, DTx, and digital clinical trial solutions sold to pharma, MedTech, life science, and health-insurance customers.
• DiGA App und Backend Paket Bundled package on MedicalOne Connect providing both a DiGA (Digitale Gesundheitsanwendung) certified mobile application and its backend infrastructure for digital health application manufacturers targeting the German market.
• DiGA Backend Paket Backend-only package on MedicalOne Connect for DiGA manufacturers, delivering the server-side infrastructure required to operate a certified digital health application.
• DiGA Services Paket MedicalOne Connect services package covering regulatory and administrative requirements for DiGA, including HealthID integration, ePA connection, MIO interoperability mapping, code validation, and invoice processing.
• DTx App und Backend Paket Bundled Digital Therapeutics (DTx) application and backend infrastructure package on MedicalOne Connect for manufacturers developing regulated digital therapeutic products.
• Standard DHT Paket Standardized Digital Health Technology (DHT) package on MedicalOne Connect providing baseline infrastructure for digital health technology deployments.
• DiGA Lifecycle Support Full-lifecycle DiGA support service covering development, regulatory approval, market launch, and post-market surveillance for digital health applications.
• Medical App Development Custom development of regulated medical mobile applications including DiGA, DTx, companion apps, and general healthcare apps compliant with IEC 62304 and related standards.
• Connectivity Solutions Secure connectivity development enabling medical devices and healthcare applications to exchange data reliably within regulated environments.
• Web and Cloud-based Healthcare Solutions Development of web and cloud-based healthcare software, including DiGA-compliant cloud infrastructure and scalable web applications for regulated medical purposes.
• Embedded Software Development Embedded software development services for medical devices, creating software integrated into medical hardware products in line with IEC 62304.
• AI / KI Development for Healthcare Artificial intelligence development services for healthcare applications, including chatbot solutions, LLM integration, RAG implementations, and AI-supported diagnostics and first-level support.
• Digital Biomarker and DHT Development Development of digital biomarkers and Digital Health Technologies (DHT) that capture and process patient-generated health data for clinical and diagnostic applications.
• Cybersecurity Services for Medical Devices Cybersecurity consulting and implementation for medical devices and healthcare software, including gap analysis, SBOM management, risk management, and audit readiness aligned with IEC 81001-5-1, BSI TR-03161, and FDA requirements.
• Quality Management System (QMS) Consulting QMS consulting supporting medical device manufacturers in establishing and maintaining compliant quality processes, backed by Bayoomed's ISO 13485 certification.
• Information Security Management System (ISMS) Consulting ISMS consulting helping healthcare organizations implement and maintain security management frameworks.
• Clinical Evaluation Services Clinical evaluation services for medical devices and digital health applications, supporting regulatory submissions under MDR and other frameworks.
• Risk Management Services Risk management services for medical devices following EN ISO 14971, covering risk analysis, evaluation, and mitigation throughout the product lifecycle.
• Usability / Human Factors Engineering Usability and human factors engineering services for medical devices following IEC 62366, ensuring user safety and effectiveness in clinical and home-use environments.
• Technical Documentation Services Technical documentation services for medical devices and software, supporting regulatory submissions and compliance with MDR, FDA, and other medical device regulations.
• Micro Consulting On-demand micro consulting providing targeted expert guidance for specific medical software and digital health project challenges.
• Market Launch (Inverkehrbringung) Services Market launch services supporting regulatory approval and commercialization of medical devices and digital health applications in target markets.
• Post-Market Surveillance Post-market surveillance services monitoring safety and performance of medical devices and digital health applications after market entry, ensuring ongoing regulatory compliance.

Quantifiable outcome

• Over 50 solutions developed successfully for pharma and MedTech customers
• +2 more outcomes

Named customers34 records

Segments4 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature5 records

Partnerships

One partnership is on record.

• YOOme Network (BAYOONET Group)coreStrategic or Co-development PartnerBayoomed is one of five subsidiaries of the BAYOONET Group operating under the YOOme brand. The YOOme network combines five specialized companies: UID GmbH (User Interface Design), BAYOOMED GmbH (Medical Software), BAYOOCARE GmbH (Legal Manufacturer), Puls Produktdesign GmbH (Product Design & UX), and Mechatronic Medical Engineers GmbH (Development & Manufacturing). Together they provide comprehensive medical device development services from idea through certification, manufacturing, and post-market surveillance.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Dosing GmbH: German digital health software developer focused on DiGA, SaMD, and regulatory-compliant medical software. Closely comparable in regulated medical-software development services and DiGA lifecycle support.
• mementor (HelloBetter): German DTx developer offering prescribed digital therapeutics, with significant overlap in DiGA lifecycle, clinical evidence, and platform integration know-how that Bayoomed serves via MedicalOne Connect.
• Selfapy: Berlin-based DiGA provider for mental-health indications, operating in the same German DiGA ecosystem that Bayoomed builds infrastructure and lifecycle services for.
• Perfood: German digital therapeutics company developing DiGA solutions in metabolic and nutrition indications, relying on the same regulated medical-software and BfArM approval pathway Bayoomed supports.
• Kaia Health: Digital therapeutics company that is also an existing Bayoomed customer (MedicalOne Connect DiGA Services). Comparable DTx product company with similar regulatory and platform needs.
• Vivira Health Lab: German DiGA provider for musculoskeletal conditions, operating in the same DiGA regulatory and reimbursement framework that Bayoomed's platform is built to serve.
• Aidhere: Hamburg-based DiGA developer (e.g., Zanadio for obesity) competing in the same regulated DiGA space where Bayoomed provides software and lifecycle services.

Emerging players

• Temedica: Munich-based digital health company combining patient-generated health data and DTx-adjacent software, overlapping with Bayoomed's digital biomarker and DHT capabilities.
• Sidekick Health: Europe-based digital therapeutics platform addressing chronic conditions, comparable in DTx product scope and needing the same regulated medical-software infrastructure Bayoomed provides.

Broad incumbents

• CompuGroup Medical (CGM): Large European healthcare-IT incumbent with overlapping DiGA, ePA, and healthcare-interoperability capabilities; also a named Bayoomed customer, reflecting both partnership and competitive overlap.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/bayoomed

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 Bayoomed