Question
A group member asks, "Does a device manufacturing site need to be GMP-certified by local authorities or is ISO certification enough for a CE mark application?" Dr. Peter Drechsler Senior TQM Manager at Allmed Medical Industries GmbH Dear all, first o...
Hey med developers, I was thinking about all the work that goes into medical devices and how much resistance there can be to design thinking so much of the time. It has become extremely popular in consumer device design, but not so quickly accepted w...
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...
Nathalie Baudry
Freelance Medical/Scientific writer - Translator - Project management chez Freelance
June 2016
In our company we produce cosmetics and some of them are going to become medical devices (class I and IIa). I would like to know if some of you have experience with this kind of changes. Are cosmetic GLP and INCI list mandatory for these MD? Thanksso...
Hello everyone! I have a question: How do you search for a needed medical device (if you need it)? Do you call or write to a manufacturer directly or do you search through your local distributor? Thank you in advance for answers! Have a good Friday!s...
I'm not sure if this is the right forum, but I'm looking for some information regarding methods of disinfection in medical facilities. I have worked on a system that was very effective in killing very aggressive agents and was thinking that other pot...
The article does not seem to make it clear, but the "stem cells" are not from the same patient, but mesenchymal stromal cells from someone else's bone marrow and transiently expressing a notch1 intracellular domain. See more on the SB623 support cell...
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...
At the MedForce Summit yesterday, we hit upon a real pain point for every sales professional in the room. Paraphrasing here, “Our sales force can talk features and benefits. But effective sales has gone beyond that. Now we deeply need to understand o...
