Question
Hi all, I'm an M.S./B.S. engineering student @ Carnegie Mellon University, and I've been doing research projects using VR for applications in prosthesis. I'm interested to hear where people think VR/AR may fall in the future of healthcare? Opinions w...
Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague ...
Just after Halloween, the FDA issued a Consent Decree to Philips Healthcare for a number of egregious violations involving their external defibrillators. Philips had “tricked” industry by consistently providing unsafe defibrillators so the FDA “treat...
After reading Urs Mattes' 31-page Chinese Medtech report at https://medgroup.biz/chinese, I think foreign company success heavily favors the largest companies with the longest time frames. Is that a reasonable conclusion based on your experience? Thi...
I am thinking of getting into medical sales any advice on what I might be getting into? Or what I should try to avoid? Also, what skills are necessary to succeed as a product sales specialist? source: https://www.linkedin.com/groups/78665/78665-63336...
Did you know that every year since 2010 the #1 reason medical device companies receive FDA 483's is poor CAPA procedures? Here's a best practice guide to help you implement a best practice approach to CAPA while avoiding the common pitfalls → https:/...
15-year-old Canadian student develops EpiPen-like gadget for diabetes patientsShaan Hooey talks to Angie Seth about GlucaMed, a product for diabetes patients that can administer glucagon in seconds.source: https://www.linkedin.com/groups/78665/78665-...
Hi everybody! Can someone tell the difference between the sentences: 1- " shall document a procedure" and 2- "shall document procedures"? Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 ...
This piece from ICON at https://medgroup.biz/mHealth got me thinking about mobile for medical devices. The points that resonated most with me: • mHealth enhances clinical trial recruitment & retention for people who AREN'T mobile; reducing in person ...
Hi all. does anybody know how one can find out which NBs have already been accredited? I know BSI have, they naturally boasted being the first ones. but is there some list or do I have to screen the NANDO? source: https://www.linkedin.com/groups/2070...
