Risk-based Development with Standards-compliant Software
When challenged with designing and developing standards-compliant software using a risk-based approach, it is essential to understand regulatory law, industry best practices, and the consensus standards recognized by regulatory bodies (FDA, ISO, and the EU). Thomas Bento helps you sort through the challenges of regulatory expectations to move confidently and defensibly forward with risk-based development using consensus standards, including IEC 62304 and ISO 14971. Learn valuable ways to augment your existing software lifecycle processes with these standards, how the standards impact industry, how to demonstrate your process for compliance audits, and ultimately how to submit to the FDA with confidence. Apply critical thinking to determine the appropriate amount of rigor for software design and development with a risk-based approach that maps your context to the Processes, Activities, and Tasks required by the standard.