American Society for Quality training and elearning webinar: Introduction to ISO 13485:2003 - Medical Equipment Manufacturing standards

This training webinar program is a intro to the ISO 13485:2003 Standard. ISO 13485:2003, which replaces ISO 13485:1996 and EN 46001.  This is an international standard providing quality management system requirements for manufacturers of medical devices.

While similar to 21 CFR Part 820 /CGMP requirements in the U.S., ISO 13485 provides additional international requirements which must be addressed for registration.

ISO 13485:2003 is based on the requirements and format of ISO 9001:2000, and these similarities are addressed in the training session.

Go here to register for this training webinar program.