ISO 13485 Course
Date and Time
April 14, 2022
8 AM - 5 PM
Becoming certified to the ISO 13485:2016 Standard can result in an organization improving product quality, reducing costs and increasing medical device market penetration. One key to obtaining and maintaining this coveted designation is having internal resources that are familiar with the organization’s quality management system and complying with the requirements set forth by the Food and Drug Administration (FDA), and transitioning from FDA 21 CFR part 11 to the consolidated ISO 13485:2016 standard. This course is designed to render capable ISO 13485:2016 Internal Auditors. In addition to providing participants with insight and skills needed to identify QMS noncompliance to the Standard and performance concerns, attendees will also learn how to plan, execute, report and follow up on internal audits.
This training is FREE however, space is limited. Participants must be able to attend ALL training sessions.