Building complex products and software is a complicated process – and one that oftentimes involves complying with a variety of regulations and industry standards from governing bodies. Ideally, compliance management involves both people and a system that is fully integrated across functions of the organization. The more integrated the compliance management in the development lifecycle, the more likely it is to detect potential compliance issues before they cause long-term harm to companies or consumers. 

In this chapter, we look at:  

• Best practices for compliance management  
• Understanding ISO standards, including their purpose and intention  
• Creating a design history file (DHF)
• Failure Modes and Effects Analysis (FMEA)