This training program will be beneficial to all personnel directly involved in medical device validation, as well as new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with validation or interact with regulatory agency inspectors to rationalize or defend validation programs will also benefit from taking this course.

Upon completion of this course, you will have a comprehensive understanding of the general MDSAP requirements that affect all five MDSAP countries, including the following content from the Audit Model. This course will be of value to all personnel whose roles would benefit from a clearer understanding of MDSAP.

This program focuses on providing an understanding of the Chinese Food and Drug Administration’s (CFDA’s) Announcement on Good Manufacturing Practices for Releasing Medical Devices, 2014 Number 64. These regulations are outlined in 13 Chapters (including 84 separate articles), which will be covered in this course.

The objective of this program is to provide you with an overview of the EU MDR 2017/745. This overview will guide you through the background of the EU MDR, why it was introduced, the EU MDR structure and timeline, the main differences between MDD and MDR, an overview of each chapter and some of the key challenges facing organizations due to its introduction.

The purpose of this program is to present the regulations and guidance information in a clear and concise manner in order to provide participants with the necessary information required to maintain the quality, safety, and efficacy products released by the company.

This program will provide an understanding of which policies, procedures and systems need to be put in place to implement and maintain compliance with the 13485 standards and some of the key advantages to an ISO 13485 certification