5 min read
Medical Device Vigilance: Important Considerations to Comply With the EU MDR
Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
Regulatory
3 min read
Agile vs. Regulatory: How the Two Coexist and Contribute to Successful Medical Device Software Development
Software is gaining relevancy in a broad range of medical devices, as it either enables the control or influence of their operation, or because...
2 min read
Basics of Drug Safety: Importance of Case Processing in Pharmacovigilance (PV)
Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...