Software that does more than just work – it stands up to regulatory requirements.
For faster time to market – and confident audit readiness.
We support MedTech and HealthTech companies, as well as organizations operating in regulated Pharma and laboratory environments (GLP) across the DACH region with software development, modernization, and maintenance. We work in line with regulatory frameworks such as MDR, ISO 13485, and IEC 62304, with a strong focus on data integrity, auditability, and traceable processes.
We work within existing QMS frameworks – not alongside them.
The types of companies we are especially relevant for
Built for organizations that need to take software in regulated environments seriously.
Mid-sized MedTech companies (50–500 employees)
HealthTech, Pharma & GLP-related environments
.webp){kind=logo}
Common challenges our clients face
These issues are not just technical – they directly affect audit readiness and market access.
Documentation
Missing or inadequate documentation makes audits, validation, and clean handovers significantly more difficult.
Legacy systems
Long-standing systems slow down further development, increase risk, and concentrate critical knowledge in individual team members.
Traceability
Lack of traceability across requirements, code, tests, and changes quickly becomes a regulatory risk.
The reality of MedTech and regulated environments
Software is not just functionality – it is part of the evidence.
In MedTech, software means: every requirement must be traceable, every change is subject to control, and every function can be regulatory-relevant. In Pharma-related and GLP-regulated environments, software is not just functionality – it forms part of the regulatory evidence.
Requirement → Code → Test → Validation
This is exactly where many software service providers reach their limits.
We are prepared for it.
Our approach
We do not work “despite” regulation – but within that reality.
Development aligned with regulatory requirements
Working in GLP and Pharma-related environments
Systems with data integrity requirements
Traceability from day one
Documentation that is actually usable
Pragmatic approach to compliance
Legacy systems? We take responsibility.
The reality in many MedTech, Pharma, and Life Sciences companies: systems have evolved over years, documentation is incomplete, technologies are outdated, and key knowledge is concentrated in individual people.
We take responsibility for systems that are already in operation.
Typical scenarios
Our approach
Without putting existing certifications at risk.
What we take on in practice
Development
Custom software (desktop, cloud, embedded) as well as extension of existing products.
Modernization
Transformation of legacy systems, and improvement of architecture, stability, and performance.
Maintenance & further development
Long-term support, defect analysis, stabilization, and controlled releases.
Compliance-related support
Documentation, test strategies, and preparation for audits and regulatory inspections.
Reference projects
Selected projects from MedTech, Pharma, and regulated environments
All projects delivered under requirements for quality, documentation, and compliance.
PMD Solutions
Rapid delivery of a mobile software layer to extend a MedTech solution for sleep-related breathing disorders and accelerate time to market.
Implantable medical devices
Logo under NDA
Support in the development of a MedTech solution for implantable medical devices – including a physician application, backend, and firmware updates – enabling secure patient data handling and reliable further development of a regulated product.
Blood donation service
Replacement of an existing DMS with a modern platform, including full migration of documents, histories, and metadata to ensure future-proof quality assurance.
.webp?width=248&height=39&name=biomedion-logo-2020%20(1).webp){kind=logo}
biomedion
We took over development, further development, and operations for this Life Sciences solution, ensuring stability, continuous evolution, and long-term operational reliability.
Semalytix
We contributed to the development of one of the world’s largest archives of patient and physician data – enabling valuable insights for informed decision-making in Pharma and healthcare.
DocToRead
Design, development, and continuous optimization of the AI-based DocToRead app, which automatically translates medical language into understandable content – improving patient education and enabling more efficient communication in healthcare.
Neo Q / RadioReport
Support in the development of the radiology reporting software Radioreport to enable structured reporting – for faster reports, higher quality, and more efficient billing and downstream processing.
Raylytic
One key challenge was migrating the existing software into a modern architecture to ensure scalability, maintainability, and future readiness.
St. Anna / Cancer Research Institute
Custom solution for structured extraction of metadata and documents from a third-party system, enabling efficient, reliable data migration and improved data transparency and usability, delivered with flexibility and on-time execution.
TooSonix
Development of the user interface and device communication layer for a focused ultrasound solution, enabling reliable interaction between software and medical hardware in a regulated environment.
A partner proven in regulated environments.
Many providers are either classic software houses without regulatory understanding – or large, expensive consultancies with limited flexibility.
European context
A partner with solid understanding of market and regulation
When we are the right partner
Let’s talk about your project
Clear. Direct. No buzzwords.
Whether it is a new development, a legacy system, or regulatory requirements – we review your situation in a structured way and provide an honest assessment.