When prompted with the question “What are the biggest challenges you are facing?”, 66% of senior management respondents to Emergo’s 2016 medical industry survey answered that changing regulatory requirements are affecting their companies the most. Somewhat related, the challenges of developing new products came in second with 45%. The importance of adhering to standards in…
Medical device development is increasingly reliant on software to enhance the functionality, operation, maintenance or user-friendliness of medical products, eventually making it easier and safer for patients and doctors to use them. However, this also adds complexity to the development of these safety-critical products. In the context of medical device development, software complexity equals risk.…
Embedded electronics and software are more and more heavily used in modern road vehicles, increasing the complexity of development processes. In order to reduce or mitigate the risks introduced by this complexity, various automotive industry standards have been devised by regulatory bodies. These aim to enforce the use of adequate processes and hazard management methods…
