Question
Elizabeth Doyle
Mechanical Engineer excited to design and manufacture medical devices and assistive technologies.
March 2018
I've been trying to find a list of materials approved for implant by the FDA with little luck. Can anyone point me towards such a list? Or do you have a personal list compiled over the years that I could use as a reference point? Application-wise, ri...
Looking for recommendations on Clinical Research Organisations to undertake phase 1/2 clinical trials for a newly developed medical device and a therapy.source: https://www.linkedin.com/groups/78665/78665-6380263623817719811
Tomorrow there is a medical device webinar from PRISYM ID on how to successfully integrate SAP with your label lifecycle management solution. This solution will accelerate your business processes through end-to-end automation. Integration benefits in...
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...
For 10 years, Dexcom made this claim: Continuous glucose monitoring (CGM) is intended to supplement, not replace, a blood glucose meter. A confirmatory finger stick is required prior to treatment. This is known as an adjunctive claim, because the mon...
Can someone share what and how he is doing packaging and labeling validation for a non sterile product ? Quantities? Parameters ? Forms ? How many batches ? source: https://www.linkedin.com/groups/2070960/2070960-6232416918385487874
Barbara Ressler
Cell Therapy Product Development Lead at Duke University Health System
December 2016
I'm looking for a good industry conference on the "geekier" side of med device development--design controls, quality systems, FDA regulations, user need assessment, etc. Has anyone attended an industry meeting on these topics that was useful and stim...
As originally asked by Erin Seiler, MBA Account Manager, Color & Additives North America at PolyOne A huge trend in labeling we are seeing on the manufacturing end, is a change from stickers or other forms of identification to laser marking technolog...
I am using Avery labels on a A4 sheet and a desktop laser printer. Can anyone suggest me software to create labels with a bar code type GS1-128 Datamatrix? I found the software "Nice label pro" that would suit me, is there any other on the market? Th...
source: https://www.linkedin.com/groups/78665/78665-6211618860588761089
