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Interacting with FDA and Regulatory Bodies

JanuaryJan 19 2023 01:00pm - 02:00pm

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Planning an FDA medical device submission?


Former FDA Team Leader and current PAVmed Inc. Vice President, Regulatory and Quality, Deepika Lakhani, and StarFish Medical Vice President of QA/RA, Nicole Ouellet share strategies and lessons from their years of delivering and evaluating medical device submissions to FDA and other Regulatory bodies.


Topics include:

• Lessons learned from a former FDA reviewer
• Regulatory pathways that enable innovation
• De novo case study
• Regulator pre- meeting briefing document tips
• Key stakeholders for a pre-submission meeting
• Positioning pre-submission meeting questions


Scott Phillips, Medical Device Playbook and StarFish Medical Founder, hosts and moderates live audience Q&A with presenters.


Average audience rating for Medical Device Playbook events: 9/10! “Honestly, I am very impressed with the caliber of guests and topics covered today. Keep up the good work.”

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