Folks

I have observed that design control and process validation are the basic requirements every employer expects from a quality engineer.

I was wondering if any one can upload tools (presentations, Excel sheets, PDFs on the same)

:agree:
:thanx:

Have you looked to see what is already posted here?

Can you bee more specific on what tools you are looking for?

Marc,

I have searched the forum but have not found any thing specially on the Design Control Process practiced in Medical Device Manufacturing Industry.

I am looking for any kind of information, process details, what steps are conducted to control the design changes for Med-Devices.

would appreciate inputs from any one on this one !!!!


Have you looked to see what is already posted here?

Can you bee more specific on what tools you are looking for?

OK - Just checking. It's a broad request.

Marc

Every bit will help.
You can start with some basic info.

here are the steps what I think ....

Design Control Process

1 Design I/P
2 Design O/P_(Device Master Records)
3 Design Review
4 Design Verification
5 Design Validating
6 Design Transfer
7 Design Changes (Design history Files)
8 Risk / Hazard Analysis

let me know your thoughts

Well, i was just trying to manage all my biomedical engineering stuff this weeking (and i´m still having troube, maybe that´s because it´s more than 18 GB of stuff :-().

Anyway, i attached some files which i got from the web on design controls (i think these, from the raps.org website, are not available anymore).


Also search the medical device link magazines for design controls - this is the search (http://google2.cancom.com/search?q=design+controls&site=devicelink-magazines&getfields=category.snippet&output=xml_no_dtd&client=devicelink&filter=0&sort=date%3AD%3AR%3Ad1&proxystylesheet=devicelink&x=0&y=0)!

Here are two more files.

These documents are a big help, thanks!!