Understanding ISO 13485: 2016

Understanding ISO 13485: 2016 History, Importance and Implementation Commentary by Kim Trautman There are many compounding factors in the timeline that affect a medical device manufacturer’s decision as to when and how to transition to the new standard ISO 13485:2016....

Incorporating the Patient Perspective

A Life Science CEO’s Guide to Success With trends in healthcare pointing towards an increased emphasis on the patient experience, life science executives are eyeing the benefits and opportunities of embracing patient-centric approaches. Many business leaders are now...

In the News

This Week’s Top Headlines Pfizer Releases Biosimilar Data, Rivals J&J Posted 2/22/17 At the six-week mark of its fifty-four-week study, Pfizer released data for its biosimilar, Inflectra as a treatment for Crohn’s disease. Previously, Inflectra was approved...