The New ISO 14155 Requirements For Medical Device Clinical Studies

Benefits in Attending:

• Understand what has changed in the ISO 14155 Standard
• Discover the new aspects of the standard and how they effect the conduct of medical device studies
• Learn how to implement the changes, including updating your standard operating procedures and quality system
• Be aware of the impact on study documentation and adverse event reporting
• Take away tips and ideas for updating your own systems or putting new systems in place to comply withthe standard

INTRODUCTION

The international standard for conducting medical device clinical investigations has undergone some significant changes which will have an impact on anyone who is planning to, or conducting a medical devicestudy. The standard has increased from a 15 page document to 60 pages and includes many additional sections with a completely different format which will have a considerable impact on the way medical device studies are conducted. The standard now includes clinical investigation planning and conduct and has separate annexes for important study documentation and adverse event reporting. If you are involved in conducting medical device studies this course will help you to understand and implement the changes.