G
Greenraisin
I'm new to this forum, but have been lurking for awhile...
First of all, I would like to know how many of you are active or have been active in the FDA regulated arena. I have been in the Medical Device business for the last 15 years, about half of it in manufacturing and R&D and the other half in Quality Systems.
Secondly, with the advent of ISO9000-2000, do any of you have any strategic plans for the restructuring of your quality systems to reflect and be compliant to both the QSR and the ISO 9001-2000? Just when the FDA came out with the QSRs to harmonize with ISO, ISO changes! If you have such plans, would you be willing to share those? In your opinion, what is the biggest opportunity presented in the transition?
Thanks in advance for your input!
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See you down life's highway!
Eric
First of all, I would like to know how many of you are active or have been active in the FDA regulated arena. I have been in the Medical Device business for the last 15 years, about half of it in manufacturing and R&D and the other half in Quality Systems.
Secondly, with the advent of ISO9000-2000, do any of you have any strategic plans for the restructuring of your quality systems to reflect and be compliant to both the QSR and the ISO 9001-2000? Just when the FDA came out with the QSRs to harmonize with ISO, ISO changes! If you have such plans, would you be willing to share those? In your opinion, what is the biggest opportunity presented in the transition?
Thanks in advance for your input!
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See you down life's highway!
Eric