An important standard for conducting medical device research is changing. How will it affect you?
Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.
This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.
Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.
But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
