🔍 Essential Insights into the "State of the Art" in Medical Devices: MDCG 2021-5 Rev. 1 Guidance
Hi everyone, I hope you are doing well and having fun, although I doubt it a bit—after all, in the medical device field, it would be weird if we didn't have problems to solve and issues to deal with. If everything's going smoothly, you're probably just waiting for the next challenge to pop up!
Today, I want to dive deep into one of the most critical concepts in medical device development: “state of the art.” The newly published guidance MDCG 2021-5 Rev. 1 details it thoroughly. For quality and regulatory affairs professionals, this guidance offers crucial directives on interpreting and applying the "state of the art" in medical device compliance...