VectorCAST: Medical Device Software under MDR – A Regulatory Insight into Safety
Ittipan Kanluan (CE plus GmbH), Hermann Rauth (Vector), Winfried Schröder (Vector)
VectorCAST: Medical Device Software under MDR – A Regulatory Insight into Safety and Security
The current health crisis illustrates once again how crucial medical devices are for the diagnosis, prevention, monitoring and treatment of diseases and for the survival of patients.
This webinar focuses on two important aspects of medical device software; safety and security. Whereas safety has been long a focus of medical device and has been reflected in many harmonized standard, security in medical device has not been concretely handled so far. The EU Medical Device Regulation (MDR) which entered into force in May 2017 contains explicit requirements regarding cybersecurity for medical devices. However, up until now, there is no harmonized standard regarding to cybersecurity for medical devices.
In the first part, the talk will present the key points in establishing software life-cycle processes according to IEC 62304 whose goal is to ensure safety and effectiveness of a medical device. The second part of the talk will discuss the approach of how to handle cybersecurity for medical devices and which other regulatory aspects are needed to be taken into consideration.