Tomorrow's Medical device software
In a rapidly emerging Medtech and IVD industry, software has become a vital component for breakthrough advances. With the challenge of ever-changing regulations, we offer a key to finding a practical and pragmatic way to navigate the various requirements placed on market players today - our way of contributing to tomorrow's breakthrough products with patient safety and benefit in focus.
developing the technologies of tomorrow
We understand the importance of embracing the future of technology in the medical device sector. Our focus is on guiding you through regulatory developments through medical device software expertise. Whether you strive to optimize your technical documentation, want guidance on how to develop products that are compliant with the latest requirements, ensure cybersecurity or navigate the Notified Body application process, our offering is designed to meet your unique needs.
Our expertise spans key areas such as risk management (ISO 14971, IEC TR 80002-1), usability (IEC 62366), system lifecycle (IEC 62304) and product lifecycle safety (IEC 81001-5-1) for Medical Device Software (MDSW). We support you not only in meeting the requirements, but also in optimizing safety and performance throughout the product lifecycle.
Our expertise spans key areas such as risk management (ISO 14971, IEC TR 80002-1), usability (IEC 62366), system lifecycle (IEC 62304) and product lifecycle safety (IEC 81001-5-1) for Medical Device Software (MDSW). We support you not only in meeting the requirements, but also in optimizing safety and performance throughout the product lifecycle.
