Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not...
Are you a supplier of raw materials, component parts or finished product to biopharma or medical device companies? The supply chain for pharmaceuticals, biologics and medical device companies are increasingly being audited by their clients and FDA. On July 25, 2013,...
The legal implications of the Sunshine Law Final Rule will be discussed by a panel of experts at the March Indiana Medical Device Manufacturer’s Council (IMDMC) March event. Topic: Sunshine Law Final Rule: How to Ensure Compliance When: March 27, 2013...
Pearl staff is attending the first INpact lunch meeting of 2013 on Wednesday, January 23rd. INpact is focused on supporting the medical device industry in Indiana. Please attend the lunch to network and learn more about the new bimonthly meeting format. Time: ...
The Midwest Discussion Group of the ASQ Biomedical Division presents Human Factors in Medical Device Development on Thursday, October 25, 2012. Jim Kershner from Eli Lilly will share his experience dealing with issues around human factors in medical device...
