Featured Articles

31. Top Device History Record Pain Points 8/25/2021

    Manual, paper-based systems to maintain their production records, or device history records (DHRs), for compliance purposes often fall short, exposing medical technology organizations to inefficient processes, poor data tracking, inaccurate or missing information, and other unnecessary risks. This white paper focuses on the pains of a manual paper system, the quality/compliance concerns around the device history record life cycle, and how a digital system alleviates such pains and concerns.

32. EU MDR: How To Prepare for The Upcoming Changes In Regulation 8/24/2021

    Recognizing the need to enforce heightened safety measures and risk management processes, the European Parliament and the Council of the European Union developed the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in 2017. 

33. The Evolution Of Medical Device Clinical Trials: Adapting To Regulatory Changes 8/24/2021

    Groundbreaking technologies are altering the very definition of what is considered a medical device, and these dynamic changes necessitate the evolution of medical device clinical trials. To minimize uncertainty and start getting a feel for the current regulatory climate, it’s helpful to examine some of the characteristics that distinguish medical device clinical trials from other clinical investigations.

34. The New Digital Pathway For Regulatory 8/23/2021

    As medical devices become more complex – mixing both device and drug delivery and/or integrating software, applications or connected sensors – the regulatory environment is becoming more challenging. Companies must strategically invest in a strong interoperable digital infrastructure, and harness data to expand their business models and position themselves to compete in a transformed environment.