Electronics Forum | Wed Aug 07 11:55:31 EDT 2002 | slthomas
Ron, have a look at http://www.fda.gov/cdrh/dsma/cgmphome.html It would be a nightmare, if your plant is not structured to support it. It's a huge pain in the fanny even when you (alledgedly) are. I'm not sure what you're pursuing, but if you're c
Electronics Forum | Mon Feb 02 08:23:03 EST 2004 | Mark
Just something we have done with our low volume cleaning of boards. Go buy a cheap steamer and a slow cooker. Let the boards submerge in the cooker at 160 degrees on a grate for about 30 mins than spray away. Don't forget the DI-water to put in it a
Electronics Forum | Thu Feb 23 02:51:20 EST 2006 | INGE
I forgot: I'm not dealing with a medical device company. But they demand the same one! See you
Electronics Forum | Tue Nov 01 14:22:16 EST 2005 | slthomas
This smells of medical device manufacturing. Am I close? At the very least you should be able to just double print one board, not single print two of them. At best, go the DOE route as has been suggested and prove to them (whomever "they" are) it i
Electronics Forum | Wed Jan 18 10:35:09 EST 2006 | slthomas
That is pretty much what we did at a previous employer. This was a medical device manufacturer so the validation had to show that the system met the current (circa 1985) standards. 'cept we used a converted fridge.
Electronics Forum | Tue Sep 14 20:21:19 EDT 1999 | Pat Copeland
I am looking for help on doing smt equipment qualifications. I need to find some examples to follow. The equipment to be qualified is a Stencil Machine, Pick and place machine, and Reflow oven. We manufacture medical devices so it has to be somewhat
Electronics Forum | Wed Jun 18 11:33:21 EDT 2008 | slthomas
Dave, can I assume that in the case(s) you're referring to, there was no gas introduced into the evacuation chamber to push any expelled moisture out of the system? In the industry I was involved with (implantable medical devices), we used nitrogen
Electronics Forum | Sat Feb 02 12:28:57 EST 2008 | slthomas
I'm sure that somewhere, some medical device manufacturer has a very proud QE with his name on 10 pages of FMEA docs describing just what catastrophic failues might occur if the blade wears out. Of course he'll leave it to the process guys to determi
Electronics Forum | Fri Jun 21 11:42:12 EDT 2013 | hegemon
It is an audit of every assembly process. Think of how ISO 9001 or 13485(for Medical Devices) might go through your Quality system, documentation, training records, etc. and apply that scenario to your actual processes and documentation of the same.
Electronics Forum | Wed Feb 10 13:47:39 EST 2010 | davef
At a previous employer, we made a wearable medical device. When a customer finished using the device, she/he returned it to the company. Then, the company refurbished the device and rented it to other customers. Before it could be refurbished, it ne