The Impact of Sterilization Modality on Connected Devices with Electronic Components
devices. The complex nature of connected devices, which often involve a combination of materials and electronic components, can...
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DHF and Design Control
In this episode, host Brandon Miller is joined by Jessica Schafersman, a Biomedical Engineer, Project Management Professional,...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Artificial Intelligence and Machine Learning Based Software as a Medical Device
In our first episode, host Erika Porcelli is joined by Lisa Michels, General Counsel and Regulatory Affairs...
Clinical Evaluation Requirements for Medical Device – Meeting Medical Device Clinical Evidence Requirements – CE Marking
Clinical Evaluations are mandated by the Medical Device Directive (MDD) to ensure the safety and efficacy of...