Engineers are often allowed to choose their own tools with the intention of maximizing their productivity, but this often leads to a product development process that is fragmented into siloed activities and data across software, hardware, quality, systems, and risk teams. In addition, this siloed process typically results in requirements (that specifies necessary dependencies and outcomes) being trapped in static documents.
In this eBook, we’ll address how implementing Living Requirements™ management helps to reduce project risk in the development process by forming a digital thread through siloed development, test, and risk activities. Living Requirements Management helps teams address the main causes of negative outcomes in the product development process by enabling:
EU MDR: What You Need to Know
Download this eBook to learn how medical device developers can prepare and implement the necessary changes ...
FMEA Framework for Medical Device Development
Download this datasheet to learn how to analyze and mitigate potential failure modes or risks for medical d...