Tag Archives: Patient Safety

A NEW VERSION OF ISO 14155: WHAT TO EXPECT?

The MDR as well as the current version of MEDDEV 2.7/1 reference ISO 14155 as GCP standard for medical device clinical investigations. Indeed, the 2011 version, but the third edition is in the making, so it can be good to … Continue reading

Posted in Uncategorized | Tagged , , , , , , , , , , , , | 1 Comment

TRANSPARENCY IN MEDICAL DEVICE CLINICAL STUDIES – THE FUTURE IS NOW

The era of full clinical data transparency is here, and that includes medical devices: EMA issued their policy on the publication of clinical data effective as of the beginning of this year, and is currently requesting feedback on the application … Continue reading

Posted in Uncategorized | Tagged , , , , , , , , | 2 Comments

WHY WAIT UNTIL THE MEDICAL DEVICE DIRECTIVE CHANGES?

The year 2012 has been turbulent for the Medical Device Industry in Europe, with the  lagging economy, but also with the scandals over the breast and hip implants, and Notified Bodies showing malpractices. These scandals resulted in an enhanced speed … Continue reading

Posted in Uncategorized | Tagged , , , , , , , , , , | Leave a comment