Question
When Tim Kringel told the 10x crowd about the data they could get their hands on, I practically cut him off mid-sentence and said, "You have to share this with the Medical Devices Group." On the spot, he agreed to give a free webinar – a must for any...
I'm now dealing with 510k, but can not understand from FDA website...From the "Deciding When to Submit a 510(k) for a Change to an Existing Device" in FDA website, it states "documentation" as document your analysis and file it for future reference. ...
source: https://www.linkedin.com/groups/78665/78665-6000838858667732993
JoAnne Moody
Adhesive Consultant ► Solving Adhesive, Coatings, & Plastic Problems ► Moving Your Project Forward ► Medical Devices
May 2015
I am creating a conference on medical device trends in the SF Bay area. As 3D printing has been used for prototyping, I am interested if 3D printed medical devices have been made in production.source: https://www.linkedin.com/groups/78665/78665-60003...
I am undertaking a research project in which I must obtain a continuous blood pressure signal from a specific patient group. I then need to analyse the signal hence it's need to be continuous. I am looking for a more affordable piece of kit than I ha...
Devendra Aher PMP®
Compliance instill confidence in medical devices to make healthcare better..!
April 2015
Recently this question came up during design review, whether rapid prototype use is effective in cadaver labs? What does it validate either product design process or product mfg process or both? Please share your thoughts. Shall we need to get compon...
Rick Satava, Professor Emeritus of Surgery at the University of Washington, is in high demand. He served in three combat missions during his 23 years as a combat surgeon in the military and spent 14 years at DARPA, the Defense Advanced Research Proje...
Hello, I am going for a CE Mark for my class IIa device. In order to understand the process better I came across STED scheme. I was wondering if someone has taken their device through STED and what was their experience?source: https://www.linkedin.co...
What are methods for maintaining spine health? Should I be hanging from my feet every morning? source: https://www.linkedin.com/groups/78665/78665-5996514797523316736
Too good not to share from my friend Gunter Wessels His main point: "Appropriateness of care” will guide coverage, payment, and utilization of your devices from now on. MYTH 1: Device tax repeal will happen. We don’t see how the device tax will be dr...
