August 28 in Cleveland, Ohio
BioOhio is once again teaming up with industry experts to bring you a program focused on regulatory issues pertinent to Ohio’s medical device industry.
This year’s event brings some of the medical device industry’s regulatory professionals directly to you. We’ll discuss changing regulations and present actionable recommendations for next steps, along with examining other critical industry trends. The event will also be an excellent networking opportunity.
This event is made possible by generous sponsorship of companies and organizations that value the power of partnerships and networking. Click here to learn more about sponsoring this event.
8:00 am – Registration & Networking Breakfast
9:00 – Opening Remarks from John F. Lewis, Jr., President & CEO, BioOhio
9:10 – Remediation and Compliance Strategies – A Case Study
Quality & regulatory leaders will discuss their strategies and experiences in remediating compliance issues and approaches for sustained compliance.
11:15 – Networking Break
11:30 – European Medical Device Regulations (EU MDR/IVDR)
Experts will lead a discussion for attendees to understand new requirements and significant changes to the EU MDR/IVDR, discuss impact to the Notified Bodies and “Economic actors” and learn about major changes in post-market and Vigilance activities, understand what products are now covered under EU MDR, and the potential impact to commercialization of legacy products due to changes in device classifications.
12:15 pm – Lunch
1:15 – Practical Thoughts about Implementing New EU MDR Post Market Surveillance (PMS) Requirements
The new EU MDR identifies very specific requirements for the PMS system to be approached through the entire product life-cycle, driving updates to the clinical evaluation, benefit-risk determination, design changes and customer information, etc. Hear what changes companies are considering and what approaches are being used to get ready for EU MDR.
2:00 – Product Testing for your Medical Device Submission/Registration
Learn about current expectations regarding data need to support medical device clearances and approvals.
- Speakers TBA
2:30 – Networking Break
2:45 – FDA Regulatory Pre-Market Approval Strategies – Case Studies
Local business leaders will discuss their regulatory strategies for bringing complicated medical device technologies to market. Presenters will share lessons learned in mapping out a regulatory strategy for medical device product clearance, and recommendations for working with FDA through the process.
3:30 – Going Global – Regulatory and Business Considerations
This presentation will provide general insight to regulatory and business considerations prior to entering various global markets. The presenter will discuss considerations related to in-country representation/ establishment, product classification, registration, labeling and other challenges when marketing devices in different global regions such as the EU, Latin America, Asia Pacific and the Middle East.
- James Russell, Director of International Projects / Regulatory Affairs Consultant, RJR Consulting
4:00 – Closing Remarks
- Laura Green, Consultant, Laura Green, LLC
Networking Reception at the Rock and Roll Hall of Fame 4 pm – 5