“We’re finding that in some parts of our regulatory portfolio, our traditional approach to overseeing certain health care products does not easily fit the types of innovations that are being developed,” FDA Commissioner Scott Gottlieb, M.D. writes in a recent statement.
When developing software for industries with rapidly changing regulatory environments, it’s critical that the platforms used are reliable, but also flexible and rigorous enough to remain compliant as requirements and standards evolve.
We may still need roads, but in the future, it’s looking like steering wheels and brake pedals might not be all that necessary.
As a child and then an adult during the great age of Sunday morning cartoons, I was especially taken with two shows that depicted the opposite ends of human development: The Flintstones and The Jetsons. The heroes both had spouses, children and pets, but while Fred Flintstone had to travel the streets of Bedrock powering […]
Smart, Internet-connected devices don’t always get the design attention they need. As a result, they may be difficult to use and lack security, and it will be hard to get different manufacturers’ devices to work together. When industry uses these devices, the problems turn into unnecessary costs and lower productivity. Leading thinkers are looking at […]
We’ve all heard the joke, “How do you get to Carnegie Hall? Practice, practice, practice.” The adage is true for many goals in life we strive for. As defined, practice is… “Repeated exercise in or performance of an activity or skill so as to acquire or maintain proficiency in it.” From an early age, we’re […]
“The biggest risk is not taking any risk…In a world that is changing really quickly, the only strategy that is guaranteed to fail is not taking risks.” – Mark Zuckerberg, CEO & Founder of Facebook Although this is true of many of today’s greatest product innovations and the people behind them, when it comes to […]
Every company that produces medical devices has to plan for that time when they must present compliance evidence to the FDA auditor. Often the most difficult and time-consuming aspect of this process is sorting through the available documentation produced by the design and development team, including outputs from multiple software tools. Even in that best-case […]
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