Design Controls News Today

DUBLIN--(BUSINESS WIRE)--The "Medical Device Design Control Essentials Course" training has been added to ResearchAndMarkets.com's offering.Participate in our immersive 2-day virtual seminar to acquire essential knowledge and establish robust processes for Design Controls in the production of safe and effective medi...

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing...

Toronto, ON (PRWEB) March 17, 2022 -- Medical device professionals know they must follow specific regulations — some of them even know what those regulations

Despite a substantial reduction in the number of inspections that the FDA conducted in FY 2021, the 483s that the agency issued are still very...

/PRNewswire/ -- Final days to register for the "Integrating Design Controls and the Product Development Process for Effective and Compliant Medical Device...

Tone Wheeler Last week’s column outlined a city plan at the heart of a radically different approach to the start of architecture studies. Instead of a series of ‘design exercises’, this first semester has students looking at the design of a whole city, then a building within that city and finally a room within that building. And that city was called ‘Opus Musivum’ or OM, Latin for ‘mosaic work’. The usual way Most architecture courses start with small design composition problems, ...

Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success By Adam Atherton, KEB, LLC The FDA conducts thousands of quality system inspections each year. The FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations here. In this article, I present background and high-level observations on the inspection data over time. My next article will analyze F...

And with that, I ask the question for which this post is named: “Can design controls accelerate medical innovation?” While this question may seem out of place, there is logic to it. This logic is based on a 20-year observation brought to into focus with 2020 vision. Innovation begins at the fuzzy front end of design, so that is where this journey begins. From this vantage point we can see significant hurdles. They are in front of us, and we clearly see them. We know that one day, down the r...