Question
Sabrina Dessources
Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
August 2015
Good morning everyone, I need some advice please! Hopefully someone can shed some light! The company manufactures IVD devices, and the QMS is currently in conformity with BS EN ISO 13485 (and all other applicable EN ISO Standards). Because we will al...
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 ...
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...
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...
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...
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...
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....
When UK-based EnXray, makers of the first low-energy X-ray sterilization tech, needed £400,000 to scale its manufacturing to hit 2018 sales projections, it turned to Crowdcube. And fantastic-looking carbon-fiber wheelchair manufacturer Carbon Black i...
Those wonderful devices you made, perfectly calibrated when customers opened the box, are still your responsibility once deployed.This guest post, courtesy of Gregg Schaeppi, Director of Client Services for PK Calibration & Validation, taught me ever...
