Medical Device Testing

Dr. James Conti participated in a conference call with the other members of ISO Committee TC150/SC2/WG6, Vascular Device/Drug Combination Products.   The meeting was called to deal with two major issues:

1) Definitions used in writing the standards for combination products; and
2) Issues to consider when a manufacturer makes a change in a material or a process at various points in the development or while gaining approval of a new medical device.