Dirk Dusharme @ Quality Digest
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.
“Climbing Stairs Just Got Easier With Energy-Recycling...
AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top...
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers...
InfinityQS
On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San...
AssurX
The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on...
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to...
Ryan E. Day
Sponsored Content
Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic...
Rob Mitchum
People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter...
Azadeh Shoaibi
The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful,...
Brenda Stodart
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
We may...
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been...
Jon Speer
If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device...
Suzanne Junod
The U.S. Food and Drug Administration’s (FDA) “History Vault” contains more than 10,000 artifacts that provide a journey through U.S. history and document the critical role played by one of the...
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the...
Michael Causey
Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will...
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not...
Robert M. Califf
About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The...
Dirk Dusharme @ Quality Digest
I’m pinch-hitting for my co-host Mike Richman in the wrap-up of this past Friday’s episode of Quality Digest Live. Mike was off on vacation last week, so I presented the show myself.
On Friday’s show...
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this...
AssurX
If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power...
