2020 - 5th Annual ComplianceOnline Medical Device Summit 2020

Medical Device Quality Challenges and Risk Management (ISO 13485 and ISO 14971) - Panel Discussion
Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP, Executive Director, Regulatory Devices & Digital Health Solutions, Merck
NanoEHS Risk Assessment Lessons for Medical Devices - Keynote Speech
Rob MacCuspie, PhD, Industry Consultant, Advisor and Scientific Director, (Former NIST Researcher)
Assessing the nanoEHS risks of nanomaterials can be facilitated by a tiered-approach framework, which can be extended to assessing risks of other new technologies being responsibly commercialized. Example risk mitigation strategies will also be identified, including in context of product development and occupational settings.
This session will provide the following insights:
Learn the key elements of a tiered-approach framework for nanoEHS risk assessment
Identify example nanoEHS risk mitigation strategies
Applying nanoEHS lessons learned to the context of medical devices
Medical Device Marketing and Advertisement, Social Media
Emerging Technologies of the Digital Health - Panel Discussion
Jyotsna Mehta, Founder, Keva Health (Ex-FDA)
Medical Device Enhancements - Keynote
FDA Invited (CDRH)
Quality Challanges and Risk Management (ISO 13485 and ISO 14971) - Panel Discussion
Techincal Writing and Documentation