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View Full Version : FDA - Design Control Forms - Medical devices (Class I and II Eveline 28th January 2005, 05:07 AM Need help! Does anybody have a form set that is easy to fill in and time efficient and fully complies to the FDA regulation for medical devices (Class I and II). Looking forward to your reply. Eveline Al Rosen 28th January 2005, 11:53 AM Need help! Does anybody have a form set that is easy to fill in and time efficient and fully complies to the FDA regulation for medical devices (Class I and II). Looking forward to your reply. EvelineI've attached a Design Control Form for Engineering Changes. It can easily be modified to be used for the Original Design. Please comment, positive or negative, for improvement purposes. big_bear1999 20th March 2007, 06:15 AM Dear Al Rosen, Great stuff on the Design control form sample. Would you mind if I print that out and show them to others who are interested to find out more about design control? It is for educational purposes only. Please reply. Thank you. Leslie. Al Rosen 20th March 2007, 01:20 PM Dear Al Rosen, Great stuff on the Design control form sample. Would you mind if I print that out and show them to others who are interested to find out more about design control? It is for educational purposes only. Please reply. Thank you. Leslie.You may use it in any way you want to. big_bear1999 20th March 2007, 09:38 PM Dear Mr. Al Rosen, Thanks so much for your reply and allowing me to use the design control form template. Regards, Leslie |
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