Greetings!
Welcome to CYPIN newsletter. Brian Shoemaker, Ph.D., Principal Consultant, ShoeBar Associates spoke at last year's Medical Devices conference. We would like to share with you the 26-page guidelines he prepared on developing software quality procedures.
Attached is a series of questions, thoughts, and suggestions for any FDA-regulated projects that need to follow design control and quality practices in developing software as part of your medical product (or whose entire product is software). We hope you will find the materials useful and thought provoking. Download the free guideline today>>Regards,
Judy Tsui
Director, Cypin Production
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