Question
CFDA announced last week new fees for registrations, with higher fees for importers of high risk Class III devices than charged to locals. This was justified on the grounds of higher costs for international inspections. Thoughts people: * Discriminat...
Jorge Franceschi (ホルヘ)
Eliminating bulk purchasing by leveraging retail pharmacy distribution channels for clinical trials. #RxStudyCard
May 2015
Time, cost, and quality are the major drivers in outsourcing research. How many members have opted to conduct their device research in LATAM? What kind of experience did you have in that country and would you do it again?source: https://www.linkedin....
This is an amazing application of 3D printing technology. I would really like one of these hearts for research! It would also make a great courtroom exhibit or teaching aid.First 3-D heart printed using multiple imaging techniquesCongenital heart exp...
In addition to inhouse production and OEM outsourcing, there are always items that make more sense to just purchase and sell as 3rd party items to convenience customers.When should 3rd party items be regulated according to a Quality Management System...
It depends, my market access and reimbursement go-to person Elizabeth Brooks said in this video interview: https://medgroup.biz/evidence. She says, "Our clients tend to fall into one of three traps. 1 - "We don't need any data." We're a 510(k) and di...
From Bloomberg: The U.S.’s biggest health insurer is considering pulling out of Obamacare, a month after saying it would expand its presence in the program. UnitedHealth Group Inc. is scaling back marketing efforts for plans it’s selling this year un...
As originally asked by
As originally asked by
Tim Hopper, MBA
Helping Medical Device/Drug Delivery Companies Accelerate Commercialization Timelines | Bringing Napkin Sketches to Life
October 2015
The boundaries between the traditional drug and medtech realms are gradually eroding, being redrawn, and then eroding again.Blurred Lines: Big Pharma's On-Again Off-Again Relationship with Medtech | QmedThe boundaries between the traditional drug and...
So, ISO 14971:2007 is officially going into a revision as deliberated in the ISO TC 210 Delft meeting today. Now the work begins!!source: https://www.linkedin.com/groups/2070960/2070960-6204883472100651009