Question
Anne-Marie Hall Henriksen
Founder & Innovator at Amazing Hall Branding & Marketing Healthcare Agency
January 2019
Dear Network, I am so lucky to stand in front of a new marketing initiative within my HealthCare Marketing & Branding Agency Amazing Hall, which will be a fantastic adventure and help so many companies. As with all new beginnings you need a littl...
Hi, I have some doubts about conformity assessment of IIa MD. We apply Annex II with exclusion of section 4. When we launch a new MD or when we make any substantial change, we always undergo an approval process with our NB.Recently, I have come acros...
It's seven years since the Supreme Court decided Mayo v. Prometheus, 566 U.S. 66 (2012). My takeaway from a three year-old conversation with Gavin Bogle (below) was "diagnostic devices aren't patentable." Of course, it's more nuanced than that, says ...
I seek a cleanroom facility (full body suit) that is sterile individually packed / triple-pack in sterile Pasteur pipettes (1-2 ml) and ship in a Cryovial. The drug is manufactured for a major multi-national firm. Who can you recommend, thank you?
Sean Linkes
Simplifying science by selling the features of medical equipment to physicians and lab leaders
January 2019
I work at University of Michigan and want to work in medical devices in some capacity. I have many years training world class physicians, lab leaders and students on how to operate million dollar instruments in a fee for service lab. I also promote t...
A Chief Technology Officer writes about Spectre and Meltdown cyber threats on medical device and clinical assets. Have you been hit by this?
A group member seeks an FDA and GMP facility to fill high viscosity gel (500,000 CP) into ABL tubes. Suggestions?
Friends, I spend 20 hours per week in my car and want to use the time productively. I'm two weeks into Medical Sales College in Sarasota (an amazing program).What podcasts, audiobooks, etc. do you recommend to further my education? I thank you in adv...
That's a fancy health tracker on your wrist. Is it medically accurate? Tracking devices – monitors, if you will – have been around for a long time. In the intensive care unit, the patient is monitored 24 hours. Your fitness tracking device may not ev...
What a treat I have for you to kick off the new year! 🥂 First, a tiny bit of news: I don't know what took me so long to realize it, but readers consistently ask me for help. It finally dawned on me. The Medical Devices Group is a Consultan...
