Molding Validation procedure - New medical component

[Ajit Basrur]

Hi all,

We will be starting the molding for a new medical component after the receipt of the mold from a tool maker. Can any one highlight on the procedure for mold validation

Thanks,
AB

 

[gszekely]

I don't know about mold validation in medical device industry. In general see below:
Qualifications Startups and Tryouts - 2nd Edition from :
http://www.wjtassociates.com/page/page/1168073.htm
and
Quality Management Systems - Process Validation Guidance
from:
http://www.ghtf.org/sg3/sg3-final.html
and browse here for article archieve, and forum
http://www.immnet.com/
a lot of good stuff and info.