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.
• 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.”