The Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on May 17, 2017 designed to provide someone new to the medical device industry a background in FDA regulation and to hone the skills of more experienced practitioners. This program has been...
Pearl Pathways is excited to announce the hiring of Michele Taylor as a regulatory compliance analyst. Taylor will help the Pearl team serve medical device and biopharmaceutical life science companies. Taylor brings 12 years of experience in Project Management in Life...
On July 27th, FDA released final guidance for Adaptive Designs for Medical Device Clinical Studies – a link to the guidance is here. According to Zachary Brennan in his article posted on RAPS, FDA received 151 comments from industry and most were included in the...
On March 10-11, 2016, the Asia Pacific Device Summit will be held in San Francisco, CA. This event will bring together medical device experts from Asia and the US. Click here for more information. Register for the event through Brandwood Biomedical, Pearl Pathways’...
Sarah Witwer will be teaching for the third time in Orthopedic Regulatory and Clinical Affairs Program this fall at Grace College. She has three decades of practice in the life science industry and is a Pearl Pathways Regulatory Compliance Advisor. Sarah is well...