Secure and reliable software for medical devices
Software development for your medical technology that meets regulatory requirements – efficient, secure, and compliant with approvals. Together, we'll bring your medical device to market faster.
Our services at a glance
We offer a full range of services for software development in the medical technology sector. From requirements analysis and architecture to implementation, verification, and validation, all the way to standards-compliant documentation. We support you throughout the entire development process with proven processes and certified quality management according to EN ISO 13485. This ensures that your software is safe, reliable, and meets regulatory requirements.
Requirements Engineering & Architecture
- Structured capture and traceability of requirements in Enterprise Architect, Polarion or your tool
- Analysis of relevant standards and regulatory requirements
- Derivation of specific software requirements from standards, regulatory requirements and specifications
- Risk analysis and definition of safety-relevant functions
- Architecture design, detailed design, interface concepts and creation of software development plans
- Creation and maintenance of traceability matrices
Cybersecurity
& Risk Management
- Implementation of the requirements of IEC 81001-5-1
- Conducting threat and vulnerability analyses
- Development of security concepts for software and system architectures
- Integration of cybersecurity measures into the entire development process
- Analysis of public vulnerability databases using SBOMs (Software Bill of Materials)
- Vulnerability scans, penetration tests, SAST/DAST and fuzz testing to verify security
- Documentation and evidence for audits and approvals
Technical documentationmentation
& Permit
- Preparation of approval-relevant documents according to ISO 13485
- Traceability from requirements to test results
- Maintenance and updating of existing documentation
- Support with certification and regulatory processes
- Providing audit-proof evidence
Software testing according to
IEC 62304
- Development of embedded and application software
- Use of validated toolchains and modern development processes
- Code reviews, unit tests and continuous integration
- Adaptation and validation of customer-specific tools
- Development in your desired programming language
Verification & Validation
- Functional, safety and performance tests
- Automated and manual testing procedures
- Conducting regression and integration tests
- Creation of complete test documentation
MEDtech engineer as partner
You benefit from our in-depth expertise and many years of experience in the development and production of medical devices. The processes we have established are now available to you as a reliable service.
We develop software that's a perfect fit for your product and your company. From the concept phase through prototyping to market launch, we support you flexibly, either on a one-off basis or as a long-term development partner.
Thanks to efficient development processes, automated tests, and validated toolchains, we deliver fast and reliable results.
You'll be in direct contact with our software developers and project managers. This allows you to quickly, easily, and professionally discuss technical questions or solutions at any time – without any bureaucratic hurdles.
With us, you receive all services from a single source: from requirements analysis through development and verification to technical documentation and cybersecurity. This ensures that your software is reliable, secure, and meets regulatory requirements. You can also take advantage of our services in the following areas: Hardware development or production consult.
References
""MEDtech impresses with its excellent, conscientious quality and absolute adherence to deadlines. From planning to production of our tVNS devices, everything runs smoothly. The high quality of the products and the professional service are particularly noteworthy. We feel in good hands with MEDtech – their advice and implementation demonstrate the experience and diligence they work with. A reliable partner that we are happy to recommend.""
- tVNS technologies GmbH
"As a young medical technology startup, we benefited enormously from the expertise, reliability, and flexibility of the entire team. The straightforward communication made the collaboration particularly efficient. A clear recommendation—an ideal partner, especially for startups!"
- Eversion Technologies GmbH
"We appreciate the constructive, goal-oriented, and reliable collaboration. This allows us to achieve our goals together within the set framework."
- LRE Medical GmbH
Your contact for medical software
