The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and international pre-market and post-market requirements, as well as key pain points in achieving regulatory compliance throughout the product lifecycle.
Located at the offices of Hogan Lovells in Washington, DC, the Summit offers an intimate environment where attendees can take advantage of networking opportunities, presentations from leaders in MedTech as well as panel and small group discussions designed to educate, inform and allow industry to share best practices and lessons learned in achieving regulatory compliance in today’s global market.
Preparing for Global Alignment in Quality Management System Regulation: ISO:13485
Keisha Thomas, Associate Director for Compliance & Quality, Office of Product Evaluation & Quality, Center for Devices & Radiological Health, FDA
Recall Patterns: Enforcement Trends and What CDRH is Looking at Today
Paterson Shafer, Managing Director, FTI Consulting
Paterson Shafer has more than 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. His domestic and international regulatory experience includes developing new product regulatory strategies, health authority interactions, submissions/approvals, labeling compliance, 483/Warning Letter/Consent Decree response and remediation program development and execution. Shafer is a strategic advisor to the FDA and has been co-leading collaboration efforts among the FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry as part of the FDA’s Case for Quality.
Reaching the Asian Market: Certification Challenges and Considerations for China and Japan
Ames Gross, President, Pacific Bridge Medical
Ames Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. He has been a featured speaker on the Asian medical markets at the Medical Design and Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society’s annual and regional meetings, and a variety of other medically oriented meetings and conferences.
AI Implementation: Best Practices and Regulatory Concerns
Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Collaborative/MIT Tech Review
Timothy Hsu is the Director of Health Technology Initiatives at AFDO/RAPS Healthcare Products Collaborative. He also serves on the Scientific Program Planning Committee for the PDA Europe 2023 Robotics & Automation Conference and on the ISPE Special Interest Group for Future Robotics. Hsu has served across the clinical, operational, and administrative spectrums in healthcare systems at pediatric, academic, research, and community hospitals. His roles in healthcare systems have included work in strategy, planning, perioperative, service line, and population health divisions.
Are You Inspection Ready? How to Create an Inspection-Ready Team and Respond to Remote Assessment Requests
Steve Silverman, President, The Silverman Group
Steve Silverman is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. His professional experience includes nearly two decades in federal service working at FDA, the U.S. Department of Justice, and the Federal Trade Commission. At the FDA CDRH Office of Compliance, Silverman led device-quality initiatives, engaged Congress and the press, and guided the office’s reorganization. He also served as Vice President, Technology and Regulatory Affairs at AdvaMed.
Securing Device Software: Emerging Cybersecurity Threats, and How to Meet Shifting Regulatory Guidances and Requirements for Medical Device Software
Moderator: Shannon Lantzy, Ph.D., Vice President of Consulting, MedCrypt
Naomi Schwartz, Senior Director, Cybersecurity Quality & Safety, MedCrypt
Rina Bhagat, Senior Director of Quality & Regulatory, Synchron
Kyle Erickson, Senior Director Product Security, Medtronic
Learn more and register here.