In light of the growing concerns regarding Corona Virus (COVID-19), we have made the difficult decision to postpone the summit.
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
Who Will Benefit?
- Quality Assurance/Quality Control
- Manufacturing and Contracting
- Supply Chain Management
- Import/Export
- Sales, Marketing and Business Development
- IT and Software
- Risk Management and Product Lifecycle Management
- Executive Management
- Regulatory Affairs
- Research and Development
- Engineers
- Scientists
- Documentation
- Compliance Officers
- Clinical/Lab
- Consultants/Service Providers/Suppliers
2020 Summit Speakers
- Darin S. Oppenheimer, Executive Director, Regulatory Devices & Digital Health Solutions, Merck
- Casper E Uldriks, Former Associate Center Director, FDA, CDRH
- Kwame Ulmer, Principal at Ulmer Ventures
- Zoe Braiterman, Consultant at GYMedical Device Consulting, LLC
- Barry Peterson, Independent Consultant, BTPeterson Consulting
- Rob MacCuspie, PhD, (Former NIST Researcher) Industry Consultant, Advisor and Scientific Director
- Kelly Eisenhardt, Managing Director & Co-Founder, BlueCircle Advisors LLC
- Jyotsna Mehta, Founder, Keva Health (Ex-FDA)
- Archana Reddy, Former Regulatory Advisor/Public Health Advocate, FDA
- Charlie Schick, Business Development, Healthcare and Life Sciences, Owl Cyber Defense
- Nathan McBride, Vice President, Global IT at Orchard Therapeutics
- Oleg Kornienko, External Service & Operations Quality Head, Novartis Institutes for BioMedical Research (NIBR)
- L. Stephan Vincze, President & CEO at Trestle Compliance, LLC
- Bill Enos, Senior Commercial Operations Director at BSI Group
- Royth v. Hahn, Global head of TUV SUD's Business Unit at Medical and Health Services
- Stephanie Harrell, Former US FDA Investigator at ProPharma Group
- Tony Rizzo, Assistant VP Healthcare Development, BSI
Please fill in your name and email to receive the Summit Agenda of this event.
Venue
Omni Parker House Hotel
60 School Street, 02108
Boston, MA, USA
Tel: +1-617-227-8600
