AAMI Expert Insights Presents May 2023 Event- Introduction to Standards for Medical Devices Online Training (Registration Fees Apply)
Event Overview
Why are standards important to medical device manufacturers? What information is needed to maximize their utility? These questions and more are answered in this in-depth introduction to the use of standards by medical device manufacturers. It also answers the need of those who wish to refresh their knowledge in order to bring themselves and their company up to speed on the latest knowledge and resources.
To Register: Overview (aami.org)
(Registration Fees Apply)
Topics include:
• What are standards and why they are important to you
• How to find standard(s)
• How to select the correct standard
• How to reference a standard in your documentation
• How to read and interpret a standard
• Regulatory bodies and standards
• Standards management in an organization
• Participating in standards creation/revision
• Resources
• “Gotchas!” to watch out for
PROGRAM-AT-A-GLANCE
Over the course of two (2) hours, the program will:
- Explain the importance of standards in medical device development and regulatory submissions.
- Understand how standards may be researched, selected and interpreted.
- Understand the basics of managing the use of standards in their organization.
WHO SHOULD ATTEND?
Medical Product Manufacturers: R&D, Regulatory, Quality and Compliance Professionals
SPEAKER
Jeff Eggleston, Master of Electrical Engineering (M.E.E./M.S.E.E.)
Global Standards Advisor, Medtronic
Member, Medtronic Corporate Regulatory Affairs group
Secretary of IEC SC 62D