Author

Oliver Strnad

Oliver Strnad covers devices and medtech for Dark Biotechnology: clearances, approvals and specifications from makers' documentation, with limits stated as limits.

Articles by Oliver Strnad

A scientist adjusts a wrist-worn prototype sensor clipped to a test rig, glass and brushed-steel lab bench in cool white-teal light, no logos.

Devices

How FDA Regulates Wearable Health Devices Between Wellness and Diagnosis

Oliver Strnad

A scientist arrays diagnostic cassettes beside an analyzer under glass and steel in a cool white clinical laboratory.

Devices

How In Vitro Diagnostics Are Regulated in the US and EU

Oliver Strnad

A quality engineer checks a checklist against brushed-steel equipment panels in a cool white cleanroom corridor.

Devices

FDA's Quality Management System Regulation Takes Effect for Device Manufacturers

Oliver Strnad