In the 6 months since the phase 1 deadline of the FDA UDI final rule, manufacturers of certain class III devices have felt the impact. The September 2015 phase 2 deadline impacts class II devices, a much larger industry population. In addition, the new EU Medical Device Regulation also requires implementation of a unique device identification program. In this webinar, UL technical expert, Linda Chatwin will share key learnings to help you and your team prepare for meeting the requirements for the EU and US, the top destinations for medical devices.
Key topics of this complimentary webinar will include:
- FDA UDI updates and requirements
- What we have learned in the 6 months since phase 1 of FDA UDI
- Tips for integration of UDI for your devices
- UDI requirements in the revised EU MDR
- Planning for UDI when launching your product in both the FDA and EU
Date: Thursday, April 16th
Time: 11:00 am EST
Location: Your Internet Device
About the Speaker:
Linda Chatwin, Esq, RAC
Manager Medical Regulatory Advisory Services North America
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the regulatory maze required to bring products to market. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Currently, she heads the North American Advisory Services group for UL, LLC, assisting clients with regulatory issues and challenges, including implementation of UDI processes. Ms. Chatwin travels worldwide to speak about changing market access issues.