J
Jeff EORL
Good Day to all.
I have a small medical device company. We are currently specification designers of Class I devices. We are preparing to move in to Class II devices. I am up dating the QS to reflect this change.
I am a novice at this QS thing. I could use some help/feedback before I bring in any consultants $$$
Can anyone comment on the SOP's I have been working on thus far.
Complaint SOP, MDR SOP, CAPA SOP for starters. In progress is the Medical Device Recall, FA SOP's
Thank you so much for this forum your feedback and help are appreciated!!!
Jeff
I have a small medical device company. We are currently specification designers of Class I devices. We are preparing to move in to Class II devices. I am up dating the QS to reflect this change.
I am a novice at this QS thing. I could use some help/feedback before I bring in any consultants $$$
Can anyone comment on the SOP's I have been working on thus far.
Complaint SOP, MDR SOP, CAPA SOP for starters. In progress is the Medical Device Recall, FA SOP's
Thank you so much for this forum your feedback and help are appreciated!!!
Jeff
Attachments
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SOP000019 Medical Device Reporting.doc36 KB · Views: 588
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medical device reporting tree.doc42 KB · Views: 357
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SOP000013 Rev C Corrective and Preventive Action.doc149 KB · Views: 561
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SOP000003 Rev E Complaint Handling.doc50 KB · Views: 648
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FRM000013-01 Rev B Request for Corrective and Preventive Action.doc44 KB · Views: 306