1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Search Results

Search Again
  1. jojo63
    Post

    Mold qualification on different machines

    NcWalker, I will work in this direction. Thank you for this discussion. :)
    Post by: jojo63, Oct 28, 2016 in forum: Qualification & Validation (Also 21 CFR Part 11)
  2. jojo63
    Post

    Mold qualification on different machines

    I will explain what we are practicing. For QO, we perform 3 small runs on a machine A: 1 run with minimum settings, 1 run with nominal settings...
    Post by: jojo63, Oct 27, 2016 in forum: Qualification & Validation (Also 21 CFR Part 11)
  3. jojo63
    Post

    Mold qualification on different machines

    Hi, I am in back. This is unfortunately not so simple. The parameters mentioned are not important (only according to the mold of capacity)....
    Post by: jojo63, Oct 26, 2016 in forum: Qualification & Validation (Also 21 CFR Part 11)
  4. jojo63
    Thread

    Mold qualification on different machines

    Hello, I'm looking your feedback in the activity sector of plastic injection. For validation, we perform an IQ-OQ-PQ on the couple injection...
    Thread by: jojo63, Jan 11, 2016, 6 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  5. jojo63
    Post

    Biological Evaluation acc. to ISO 10993-1

    The first user is the notified body. Sales volumes of our device are low. Our goal is to demonstrate the biocompatibility as simply (but according...
    Post by: jojo63, Oct 16, 2015 in forum: EU Medical Device Regulations
  6. jojo63
    Post

    Biological Evaluation acc. to ISO 10993-1

    Hi all, I search information to address the same problem. We manufacture a vaginal applicator. I identify two identical products manufactured...
    Post by: jojo63, Oct 13, 2015 in forum: EU Medical Device Regulations
Showing results 1 to 6 of 6
Search Again