• Feature ArticlesFeature Articles

    Postmarket Surveillance and Postmarket Clinical Follow-up

    This article discusses the scope of postmarket surveillance activities within the European Union (EU) as set out in Medical Devices Regulation (MDR 2017/745) . 1 The author explains the difference between postmarket surveillance (PMS) versus market surveillance regarding regulatory compliance, discusses PMS plan minimum technical content, persons responsible for regulatory compliance, PMS reporting, types of reports, postmarket clinical follow-up and transparency, accoun...
  • Feature ArticlesFeature Articles

    Global Medical Device Cybersecurity Compliance Requirements

    This article discusses compliance requirements to maintain global medical device cybersecurity. The author provides examples of recent cybersecurity breaches and also reviews efforts made by regulatory agencies in the US, Australia and China to be proactive in encouraging better cybersecurity, offering tools and tips to help a variety of healthcare organizations to achieve better cybersecurity.   Introduction   Cybersecurity can be defined as a process for preventi...