ComplianceOnline, Omni Parker House Hotel, Boston, MA
04/16/2020
Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations. Why you should attend this summit Future Trends of Medical Device Regulation, Risk Management, UDI, Recall Complaint Management etc. Listen from FDA/CDRH Directors: What is Critical to Quality Get Update on FDA compliance Listen from FBI: Cyber Security Risks Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion Explore Upcoming Changes in Medical Devices under Trump Administration Change Management Criteria for Supplier Quality Agreement Establishing a Medical Device Security Program Panel Discussion FDA Warning Letter FDA Enforcement FDA Interaction For More Information: https://www.complianceonline.com/medical-device-summit-seminar-training-80231SEM-prdsm?channel=hum-molgen
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Invited Speakers:
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Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP, Executive Director, Regulatory Devices & Digital Health Solutions, Merck Kwame Ulmer, Principal, Ulmer Ventures (Ex-FDA) Zoe Braiterman, Consultant, GYMedical Device Consulting, LLC Barry Peterson,Independent Consultant, BTPeterson Consulting Tony Rizzo, Assistant VP Healthcare Development, BSI Rob MacCuspie, PhD, Industry Consultant, Advisor and Scientific Director, (Former NIST Researcher) Casper E. Uldriks, Former Associate, Center Director of FDA's CDRH
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