Question
Do you control design changes differently during pre-transfer segment of design and development project, during design transfer and after product release?All changes must be reviewed and approved, but how much control is necessary prior to verificati...
I am using Avery labels on a A4 sheet and a desktop laser printer. Can anyone suggest me software to create labels with a bar code type GS1-128 Datamatrix? I found the software "Nice label pro" that would suit me, is there any other on the market? Th...
Mohamed Zitouni
Principal | Senior Procurement and Supply Chain Consultant | Chain Bridge Services
July 2018
Hello members, I am a Procurement and Supply Chain consultant for a Medical Device startup which is building a prototype. I have a question about a process. Would you consider the prototype stage a part of the FAI process or will you conduct this sep...
I'm really hoping this message gets out to anyone planning a clinical trial, so please forward it to your network. This is an ambitious post, sharing two great 10x Conference presentations.Doug Fankell, Ph.D. (on left) is an engineer with Structural ...
source: https://www.linkedin.com/groups/78665/78665-6211618860588761089
I would like to know if some of you have issues with this procedure ? What is your Notified Body and does it still accept OBL procedure for CE marking ? I think that is a huge concern for many Medical Device companies and it deserves a discussion. so...
In layman's terms, post-market data means regulators want to know how your market is doing in the marketplace. Christine Zomorodian and Anne Leijsen gave an easy-to-follow talk about it at the 10x Medical Device Conference in October, 2018. Before we...
Amy DeWinter
Founder, Ascenda Medical Marketing | Expertise in Advancing Medical Technology
November 2019
Hello, Med Device Community. I am consulting with an early commercialization company that has a device used in emergent situations, so use is not planned. Our challenge is trying to collect evaluation forms for prospective accounts with the intention...
I had been trying to get a packaging expert on the 10x stage for three years because we'd never covered it in depth as a group. It was worth the wait. Adept Packaging sent 35+ year veteran Jan Gates to speak and she did not disappoint. This video is ...
I'm trying to put together a very high level view of medical device development for novice (meaning no prior experience in the industry, not just this is their first invention) inventors. I am interested to hear from others what (if any) role they ha...
