Question
A rather explosive conversation started in the group this week when @Richard Bollinger posted "FDA compliance crisis still a threat." His post, verbatim: "New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections s...
source: https://www.linkedin.com/groups/78665/78665-6343475714100064259
New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections still get CAPAs that are voluntary or official actions. This holds true going back to 2009. See the chart below. Note the black line that holds steady as th...
Even though the Corrective and Preventive Action (CAPA) process is at the heart of any quality management system, CAPA violations are the most frequently observed Quality System subsystem cited by FDA. It happens year after year – and regardless of t...
Folks, Eager to know, if there exist vendors/platform to connect multiple health parameters (BP, TP, Glucose, ECG & much more) from monitoring devices of the patient. This is basically to monitor the patients remotely.Thanks!source: https://www.l...
Our product received CE certification. In addition to the product labels and IFU, We would like to indicate in our product' catalogue the CE Marking with N.B number. Is it allowed? Please explain/Make citation.Thank you.source: https://www.linkedin.c...
Hello, I am working in local medical device importing company. I'd like to listen to your experience and opinion about Application of ISO14971 to the Sales site independently. We are not a manufacturer and there are no local regulation or obligation ...
Dave Fornell
Editor - Diagnostic and Interventional Cardiology (DAIC) at Scranton Gillette Communications, Inc.
November 2017
5 Tips for Medical Device Engineers on FDA Design ControlsIf you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel lik...
Claude P. Bobin
President at T-MedRobotics, Adjunct MBA Professor at Benedictine University
November 2017
source: https://www.linkedin.com/groups/78665/78665-6339193416852738052
I'm sorry it's taken me so long to share this: Kirk Zeller, DBA gave a fantastic presentation on the Japanese market at this year's 10x Conference. Catch the video at https://medgroup.biz/Japan This fascinated me: Despite having 40% of the US populat...
