Question
It appears this topic was covered in this forum back in 2012 and the HIDA conference was suggested as a possible resource. I've heard both positive and negative experiences concerning finding medical device distribution partners at HIDA and was hopin...
As originally asked by Erin Seiler, MBA Account Manager, Color & Additives North America at PolyOne A huge trend in labeling we are seeing on the manufacturing end, is a change from stickers or other forms of identification to laser marking technolog...
Hi all. does anybody know how one can find out which NBs have already been accredited? I know BSI have, they naturally boasted being the first ones. but is there some list or do I have to screen the NANDO? source: https://www.linkedin.com/groups/2070...
An independent reviewer is required for Design Reviewes. The problem in small start-up companies is that everyone is involved in the process and no one is really independent, on the other hand an external consultant may be very expensive for those co...
First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
I recently reviewed a sterilization validation protocol for a client and I thought some of you might be interested in the things that needed to be modified:1. Make sure you specify the revision of all standards referenced and make sure the version is...
Hello everyone,First, thank you for accepting me in your group.Can sterile medical devices be re-sterilized and used as new and according to standards/lows if they expired (as a product) but haven't been used? Re-packaging is also required?Thank you....
Our beloved King Charles Cavalier, the first pet I've ever had, died on Saturday. It hit me harder than I thought it would. Named after my hometown, 11-year-old "Brooklyn" had a biopsy on Friday. We learned he had cancer of the mouth. We decided as a...
Why I ask this? As a physician sometimes I have a feeling that in this group I'm not at home because it's mainly a group of businessmen, salesmen, distributors, engineers and others outside health practice with quite another way of thinking. Many of ...
Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?The devices are not cleared and some may or may not be on a path to...
