Question
I'm trying to understand which countries' regulatory bodies have country of origin requirements and what does "country of origin" actually mean for these countries. Which countries have "country of origin" approval requirement for medical devices?If ...
Anyone here have any initial thoughts about the potential impact of Brexit on CE Marking?What is likely to happen with CE certifications issued by BSI or other MHRA-designated notified bodies?Is Brexit likely to have an impact on the process for fina...
Hello my esteemed colleagues!! I am attempting to learn as much as possible about the United States regulations and codes specifically regarding Medical Devices. I have a full list of predicate devices that I can prove do similar things to our device...
Katie Weimer from 3D Systems gave us a gift: The most informative update on 3D printing for medical devices. Here are the entire video, slides, and transcript: http://medgroup.biz/Katie-in-3D She fascinated us with before-and-after patient photos who...
With the new EU Medical Devices Regulation and IVD Regulation more or less established now, let's take a look at the transparency requirements under these regulations. This presentation was delivered at Informa's MedTech Summit in Brussels on 14 June...
FDA's New Biocompatibility Guidance is here. It's a detailed, lengthy guidance, with a strong emphasis on risk management grounded in a thorough knowledge of device materials toxicology. This is a very different guidance from the old G95-1. FDA Bioco...
I was the first graduate from UT Austin EE department with a biomedical degree many years ago. Worked in EE labs, Marconi and TI during my undergraduate school years, then I went to biomedical graduate school in Houston for a PhD that I did not compl...
HiI am curretly updating our internal SOP's after a notified body audit found that we did not comply with the latest version of the ISO 14971 2012 Std. Specifically, I am interested in how others have updated SOP's to comply with Annex ZA and how thi...
Michelle Springhorn Kingsbury
Transportation Supply Chain Logistics provider of innovative shipping solutions
June 2016
Are you or your 3PL maximizing the cube in your shipping container? What if you could double stack odd size, fragile, or high value units on frames and ship damage free? Is that cost savings important to the medical device community?
In this post by David Amor, CEO of Medgineering, he breaks down what small med device companies should know about their quality systems and how FDA views themsource: https://www.linkedin.com/groups/2070969/2070969-6149239725870895105
