We have been a software company in the fields of medical technology, pharmaceuticals, sports and life science for over 40 years. Our customers rely on our in-depth regulatory know-how, our ability to quickly familiarize ourselves with complex technical environments and our expertise in harmonizing efficient processes with the highest regulatory requirements. Patient safety and innovation are our top priorities. With our many years of experience in software development for medical devices, software quality assurance and process consulting, we make a decisive contribution to healthcare and drive technological progress in the industry.
Patient safety and innovation are our top priorities. With our many years of experience in software development for medical devices, software quality assurance and process consulting, we make a decisive contribution to healthcare and drive technological progress in the industry.
From conception to certification, we develop customized software solutions for medical devices - compliant, safe and efficient. Our agile factory enables us to design development processes flexibly, integrate innovative technologies and meet the highest regulatory requirements at the same time. We rely on modern architectures, AI-supported applications and user-friendly interfaces to develop future-proof and patient-oriented medical technology software.
With our test factory, we ensure that your software for medical devices meets the highest quality standards. Our range of services includes automated and manual tests, validations in accordance with IEC 62304, performance and usability tests as well as cybersecurity checks. Using a risk-based approach, we optimize the testing effort and guarantee safe, reliable and error-free software that meets the requirements of the MDR (Medical Device Regulation) and the FDA.
The regulatory requirements for medical device software are complex and constantly changing. Our experts support you with standards compliance in accordance with IEC 62304, ISO 13485, ISO 14971 and MDR, guide you through the entire certification process and help you to overcome regulatory hurdles efficiently. Whether software as a medical device (SaMD) or embedded software - we ensure that your product meets the legal requirements and is successfully launched on the market.
Cybersecurity in medical technology is essential to protect patient data and ensure the safe operation of medical devices. We support you in the implementation of security strategies, risk assessment in accordance with ISO 14971 and compliance with FDA and MDR safety requirements. We also take on requirements and project management to ensure structured, standard-compliant and efficient development of your medical technology software.
To keep your teams up to date, we offer individually tailored training courses and workshops on all relevant medical technology software development topics. Whether IEC 62304-compliant development, regulatory requirements, agile methods in medical technology, software testing or cybersecurity - our experts impart practical knowledge and best practices so that you can confidently meet the increasing demands of the industry.
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