Today’s move-fast-get-it-to-market-yesterday product development culture puts a lot of pressure on companies to innovate quickly, but creating a safety-first culture can save you from product recalls and failure.
The US Food and Drug Administration (FDA) has issued new guidance that expands the Abbreviated 510(k) Program for medical device development and premarket notification submissions.
Formal and informal reviews may necessitate different things from each of these roles, but we’ve compiled a list of best practices by role to make reviews go quickly and smoothly.
As more companies pull design functions in-house, knowing how to properly execute a good product design critique is becoming a core competency for development teams.
For decades, systems engineers have participated in new product development processes on internal teams, driving complicated projects to market under old rules, methods, and technologies. But today’s highly-competitive markets offer new complexities that no longer work within the old rules of product development.