Pre-Conference Training Day

8:30 AM - 9:00 AM Registration and Welcome Coffee

09:00 - Readiness Review Begins
The audience will divide into three interest groups: implantable and traditional devices, software-controlled device, and in-vitro diagnostic. Each will nominate one "reviewer" who will ask questions from a list provided by the instructor - other delegates in each group will help fill in the type of information required.
What you will learn:
* Typical key areas to be covered in a device submission
* How to identify and fill gaps in information for a submission

10:30 - Morning Coffee Break

11:00 - Readiness Review: Lingering Questions
11:30 - Deep Dive - Description and Labeling
Explore key high-level information needed in a submission:
* Description of device - intended use, principles of operation, engineering information, surgical details as appropriate, system concerns
* Labeling - device label information, instructions for use, warnings, contraindications, package label; UDI

12:30 - Networking Lunch

13:15 - Specific Topics Part 1
Explore key high-level information needed when considering the following challenges:
• Sterilization
• Shelf Life
• Biocompatibility

14:45 - Afternoon Coffee Break

15:15 - Specific Topics Part 2
Explore key high-level information needed when considering the following challenges:
• Software
• EMC / Electrical Safety
• Performance Data
• Hazard Analysis

16:00 - Training Day Conclusion

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Brian Shoemaker, Ph.D.

Principal Consultant
Shoebar Associates