Global Medical Device Podcast powered by greenlight.guru
About This Show
The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Most Recent Episode
The Intersection of Medical Device Usability and Risk Management
2 days ago
Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the intersection of usability and risk management. There are so many tips and great pointers that you will not want to miss this show. Have a pen and paper or your note-taking device available, because this episode is chock-full of information that you won’t want to forget.
Some of the highlights of the show include:
● What usability means and how it applies to the medical device production process.
● Where the FDA stands on the topic of usability and what types of guidance documents are available.
● How the topic is handled by international and world agencies in addition to the FDA, as well as how cultural differences can impact usability studies.
● The difference between a usability study and a clinical trial. A usability study is focused on the user and a clinical trial is focused on the patient, but today, the two are often one and the same.
● Why usability needs to be more “real-world.” Many times, what the engineer intends is not how the doctor or surgeon will actually use the device.
● The importance of instructions for use and labeling, and how that relates to risk management.
● The relationship between usability and product liability.
Rated 5 out of
Very educational and fun
Pretty unique and intriguing insights into the medical device industry from some great guests. Surprised by how actionable and helpful many of the tips and pointers are.
Date published: 2015-09-11
Rated 1 out of
Green Light Guru Sucks
Can't say this enough bad things about this platform. Isn't FDA compliant at all despite them saying it is. Document management sucks. Avoid this software platform at all cost
Date published: 2017-01-30