Electronics Forum: medical device (Page 1 of 5)

Is there a medical rating and standards for PCB components

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

Cleaner device for PCB

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

SMT line validation

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

Screen Printing Print Validation

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

Dry Box Storage

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.

IQ/OQ, and PQ

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

Baking components at 70 degree

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

Squeegee replacement

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

Nadcap certification

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.

Contaminated product from field

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

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