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.
10:00 – Current FDA Inspection Issues: FDA Panel Discussion & Q&A
- Moderated by Laura Green, Consultant, Laura Green, LLC
- Ben Dastoli, Investigator, FDA
- Laureen Geniusz, Investigator, Cincinnati District, FDA
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.
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 – Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety
Medical device organizations that manufacture products that involve patient contact are almost always required to perform some level chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety. Discussed will be: Examples of when and how to leverage extractables/leachables to address various changes in materials or manufacturing processes; The utilization of extractables/leachables on a new medical device; Time will also be allotted for discussion of real-world case studies and Q&A.
- Don Pohl, Principal Product Development Strategist, NAMSA
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
Networking Reception at the Rock and Roll Hall of Fame 4 pm – 5