Learn how FDA expects you to develop, implement, and manage Design Controls for your products -- all from globally respected device compliance experts and ex-FDA investigators.
- Focus on overcoming one of the biggest obstacles that routinely confounds device-makers: accurate and consistent product design transfer to actual manufacturing operations.
- Better understand what to include in the product Design History File (DHF) and Design Master Record (DMR) -- and just as importantly -- what FDA inspectors look for when they review your records.
- Know when and how to validate or verify product design, and what's the important difference between the two.
Learn how to comply with FDA’s growing expectations for Device Design Control and successful transfer to the production line.
Design History Files…Device Master Records…Essential Design Inputs. Design control is required for all medical devices sold in the U.S., EU, Japan, and several other countries. In addition, there’s relentless pressure from both FDA and Congress to improve device design control and manufacturing.
To ensure you’re meeting FDA and global standards, enroll in this proven EduQuest course, which has successfully trained thousands of medical device quality professionals worldwide since 2008.