Question
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...
Andrew Kyle
Medical Devices, Internet of Things, Agritech and Cannabis Speaker-Consultant
December 2016
It is time to change the attitude toward cannabis. This group has the voice that may make a difference. We are in the medical field to help and be blind to our individual prejudices. Even if you don't believe in cannabis, your prejudice should not co...
Under Trump, the medical device industry will likely be the first to benefit from tax cutsDonald Trump and the Republican-led Congress are likely to permanently repeal the medical device tax, according to lawmakers, lobbyists and industry...
My friend Stephen Carter from Mewburn Ellis gave a 10-minute talk about the European Unitary Patent Package at the 10x Medical Device Conference in May 2016 – before the Brexit vote. His worthwhile summary at http://medgroup.biz/EU-patents (free acce...
Kristin Benokraitis
Director of Quality and Operations at EG-GILERO: A trusted partner for medical and drug delivery devices
December 2016
We are working with a pharmaceutical company who, in the past, developed a combination product (drug/device). Because the device was included in the drug submission, it led to many questions, specifically about the device, by the agency because both ...
Hi all, I am looking for a simple protocol to file a 510k exempt device to FDA, since FDA provides so much detailed information of 510k and PMA on the website. I will be grateful if someone could share some simple tips of what I should do for the 510...
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...
“Notified Bodies (NBs) are getting hit with a crush of work so great that you’re lucky to get a callback,” says Medical Devices Group Advisory Board member Rob Packard. NEW WORK: The European Parliament and EU Council are expected to approve the new ...
