12:00 p.m. – 1:00 p.m.

Registration

1:00 p.m. – 1:15 p.m.

Welcome and Introduction by Chairperson

1:15 p.m. – 2:00 p.m.

FDA’s 2020 Medical Device Regulation Agenda: CDRH’s Priorities

Are you addressing CDRH’s top strategic priorities for FY 2020 head on? If not, your devices might be left behind.

This session will enable you to get ahead of your competition:

• CDRH reorganization — what it means for your devices and processes
• Comparing QSR v. ISO13485:2016
• Get ready for new software validation guidance documents
• How to address moving to a risk-based inspections approach — and what inputs will influence your results
• MDSAP program — what it means for your processes
• The truth about FDA’s new shipment examination program at ports of entry

2:00 p.m. – 2:45 p.m.

Implementing the Clinical Evaluation or Performance Evaluation Process

Do you know the ins and outs of the clinical evaluation system (EU-MDR) and performance evaluation system (EU-IVDR) requirements? If you’re looking to obtain a CE Mark, this presentation is a must.

Gain the tools you need to ensure success:

• Secrets of the new requirements for clinical and performance evaluation
• How to prepare your documents to meet the notified body’s (NBs) requirements
• Using the NBs review process to your advantage
• The best way to respond to issues raised by the NBs
• When it benefits you not to perform a clinical evaluation or performance evaluation — and how to document and present that decision

2:45 p.m. – 3:15 p.m.

Refreshment Break

3:15 p.m. – 4:45 p.m.

Panel Discussion: EU-MDR & IVDR QMS

Is your quality management system foolproof? While the new EU regulations require a quality management system with significant extensions from ISO 13485:2016, chances are it only partially covers the regulation’s requirements. In some cases, ISO 13485:2016 might not cover any of the requirements. Where does yours fall? Are you compliant?

Attend this session to discover:

• Takeaways of the tools, methods and checklists you must have to implement an effective and compliant quality management system
• The areas where ISO 13486:2016 does not meet the requirements of the regulations — and how to close the gaps using CEN/TR 17223:2018

4:45 p.m. – 5:30 p.m.

Impact of New Economic Operators on You, the Manufacturer

The EU-MDR has six types of economic operators and the EU-IVDR has four — each with specific and well-defined requirements in their relationship with you, the U.S. device manufacturer. Understanding the specialized roles of each economic operator is vital, while ensuring economic operators’ accountability is key to compliance — and key to business success in the EU.

Gain insight on enforcing economic operators’ accountability to be compliant:

• Understand the specific role each economic operator plays in bringing a device into the EU and getting it to customers
• The interconnections among the economic operators (verifying activities, information exchange, product liability requirements and insurance obligations)
• How best to map the distribution channels
• Get a handle on the supplier management requirements and contractual obligations
• The essential elements in the contract between you and each economic operator
• The economic operators’ obligations to the competent authorities

5:30 p.m. – 6:30 p.m.

Networking Reception