Question
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...
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...
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...
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
This week I am in Brussels at an international conference on medical device regulations. The most popular topic of discussion is the new European Medical Device Regulations that was confirmed on May 25 and published on Monday—the first day of the con...
source: https://www.linkedin.com/groups/78665/78665-6146716667671044098
Barb Sichel
Director Business Development, Translations at International Language Services, Inc.
June 2016
At what point in your CE process do you look at translating your product documentation? Is this part of your overall plan or handled market by market, as you branch into new regions?source: https://www.linkedin.com/groups/78665/78665-6146449808384147...
As originally asked by
During the 10x conference in San Diego last month, we discussed the changes to the EU regulations for CE Marking. If you are interested in downloading the slide decks for free, please visit the following link:http://medicaldeviceacademy.com/10x-2016/...
