Medical device functional safety plays a central role when motors, sensors and software control movement or other potentially hazardous functions. How can these aspects be integrated into device design and risk management?
The technical article “Medical Devices and Machinery Regulation: The Challenge of Functional Safety”, by Maria Santoro, Specialist Engineer of Teoresi MedTech, explores the relationship between the Medical Device Regulation (MDR) and European machinery legislation. Using examples ranging from surgical robotics to extracorporeal blood treatment systems, it discusses how to design and validate safety functions by considering the interaction between hardware, firmware and actuators.
The article also examines how standards including ISO 14971, ISO 13849-1 and IEC 62061 can support an integrated approach, offering useful insights for teams developing automated medical devices.
Read and download the paper to explore the role of functional safety in medical device design.