Machinery Regulation and NRTL Certification - Requirements in EU and USA

The importance of software in connection with electrically powered medical devices or as an independent product has grown significantly. The change has caused that more and more often the assessment of the patient's condition and the decision to treat or not to treat is based on the results calculated by the software. The use of software in medical devices obliges the manufacturer to demonstrate that the software is safe, compliant and high-performance. There are also requirements for the software development, usability and risk management process used to design the product.

Risk management is a key factor in assessing the safety of medical devices. MDR and IVDR requirements also require risk management to be taken into account as part of the quality system.