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Whew. You got through the unique device identification (UDI) submission process. But you're not done yet. In http://medgroup.biz/UDI-next-steps, John Lorenc from Reed Tech explains UDI doesn’t end with your submission to the FDA’s GUDID database. "Af...
Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, "At this point, diagnostics are really not patentable." I recorded his 5-minute answer at http://medgroup.biz/not-patentable Gavin: Under “The Mayo Clinic v. Pr...
An AmericanEHR Partners survey said just 34% of physicians were satisfied or very satisfied with their EHR system in 2014. I'd say this is bad: • 72% said EHRs made it difficult to decrease their workload • 54% complained about higher operating costs...
Do you get The MedTech Strategist? You should. Here's a free copy: http://medgroup.biz/free-strategist Their Feb 9 issue has a 20-page article on 2016 tech innovation. These caught my eye: • Transcatheter heart valves top their list. Edwards (50% sh...
... said a Minneapolis-based medical device CEO on condition of anonymity. He was reacting to "Medtronic merger tax advantages bring in $9.3 billion" at http://www.medgroup.biz/MDT93 And specifically the first line, "Medtronic says tax advantages ste...
I am collecting new evidence about last and innovative medical devices and apps to verify what are those most used around the world and how they can or should be known in Italy to better serve Patients and their Medical doctors. Would you help me to ...
What kind of RFID is used at your workplace, active or passive? How reliable is it? What are the difficulties in managing it? And, what changes would you make if you could? We use active system based on infrared tagging and WiFi reporting. It has som...
And 200,000 is the low estimate. Medical errors will take 200,000+ lives in the U.S. this year. It's 3 million lives worldwide. I attended the World Patient Safety Forum this weekend and learned: - Medical errors are the third leading cause of death....
Folks, this is going to play out over time. I'm posting the link below figuring some of you remain interested in Theranos like I am. Strikes me they're going to continue making headlines for some time.http://upstart.bizjournals.com/companies/startups...
Dr Fatima Zaid Abu Zanat
Regional Regulatory Affairs & Scientific Office Manager at Mundipharma International Limited
January 2016
Hi Colleagues!Does anyone have the medical device regulations/ guidelines for West Africa (Ivory Coast, Senegal, Mali, Cameroon, and Gabon)?How long does it approximately take to complete the registration process especially for Class IIb and III medi...
