Safe medical engineering —
what digitalization and networking mean for the cybersecurity of your medical equipment.
Standards and legal requirements —
which regulations manufacturers and operators must observe.
Possible solutions —
how to implement cybersecurity requirements during design and throughout the entire product lifecycle.
What opportunities does the IoMT and the e-health market offer?
What are the regulatory requirements?
Which security-relevant standards must be considered?
What guidelines and guidance are available to manufacturers?
What can manufacturers do to safeguard their products?
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.
