Regulatory Reporting Posts

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve already covered the impact of recent eMDR regulation updates on the industry (the overall benefits for patients and the health care community as a whole) in a previous post. Now let’s take a closer look at why medical device manufacturers may not want to delay their transition to electronic medical device reporting. (more…)

Notified Bodies and Clinical Evaluations

Mark Crawford

Nancy J. Stark is president of Clinical Device Group, a medical device clinical consultancy based in Chicago. Recently she has noticed an increase in requests for clinical evaluations and offers advice about how to write clinical evaluation reports to meet the requirements of notified bodies. (more…)