Join the IEEE Boston Consultants Network on Tuesday, December 3rd, at 7 pm for the third installment of our Consultants Series: Consulting 301 - The FDA Medical Device Regulatory Process. This is a free event, open to anyone.
I will be providing an overview of the FDA Quality System Regulations. This presentation is designed for consultants interested in medical device development and manufacturing, but it is open to anyone seeking a broader understanding of the field.
The presentation includes an explanation of a Quality Management System, the FDA Quality System Regulations, ISO 13485, and the recently introduced FDA QMSR. Along the way I will introduce common processes and buzzwords used in medical device development and understanding risk from a consulting perspective. The presentation wrap-up provides provides suggestions for areas of opportunity for consultants in medical device consulting.
The presentation starts a 7 pm but the meeting starts at 6:30 for attendee introductions and networking. If you are interested in attending, you can register here. The Zoom link will be provided in your registration confirmation email.
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