See ISO/TR 24971 for guidance on selected risk analysis techniques, including those for in-vitro diagnostic medical devices.

Implantable cardiac devices include defibrillators, pacemakers, and their associated electrical leads. Practitioners implant these devices during either an inpatient or outpatient procedure.

This guide provides an overview of how health insurers evaluate and determine coverage for new medical devices, including those typically covered by insurance (e.g., diabetic glucose …

Feb 24, 2021 · In response to the National Strategy, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) led an effort to develop recommendations …

Explore how software for device I/O is architected. Discuss OS considerations at multiple software layers. Investigate an example device driver. How do we enable interactions with so many …

In general, an unapproved medical device may be used only on human subjects when the device is under clinical investigation and when used by investigators participating in a clinical trial.

The process for applying for a medical device or drug manufacturing license is described in the respective instructions for filling out each application. The medical device and drug license …