Question
Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, "At this point, diagnostics are really not patentable." Watch the five-minute video to understand why he believes this. Joe Hage: Hey, it's Joe, I'm here with G...
Does anyone have the list of the COFEPRIS approved TPRs? Thanks in advance!source: https://www.linkedin.com/groups/2070960/2070960-6109166341242056708
If the company is OBL (orginal brand label) and does not have own iso 13485 certificate can register products in Australia (and be "legal manufacturer)? I should mention that OEM (orginal equipment manufacury) owns iso 13485 certificate so these prod...
After watching this release get pushed back quarter after quarter for longer than some documents exist, does anyone in the group have any visibility on when ISO13485:2016 (2017?) is actually likely to be released. Or even what the review status of th...
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...
Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate "a medical device that is intended to be used as an in vitro diagnos...
A client of mine recently received a FDA Form 483 with multiple inspection observations and they wanted to know how to prioritize their corrective actions. Typically companies will work on corrective actions for each 483 observation in parallel. Howe...
... 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...
Dear all,For devices of similar indications as product code KNW (Gastroenterology-urology biopsy instrument), several microbiology testing labs have mentioned that 3 samples is sufficient for sterilization and cleaning efficacy validation for a 510(k...
