This whitepaper shows that product and patient safety in a digital, networked medical environment is not possible without information security. Regulations such as the Medical Device Regulation (MDR) therefore formulate high cybersecurity requirements for medical devices. The requirements are not limited to the design and development process, but cover the entire product life cycle.
However, the legal requirements - above all the MDR - are often unspecific with regard to the implementation of the requirements. We are happy to support you when it comes to concrete implementation. Based on decades of development activity for safety-related embedded systems, we have developed a structured process to support companies in the MDR-compliant development of their products and the comprehensive safeguarding throughout the entire product life cycle.
