Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents
This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices.
Medical Device Testing Requirements for 510(k) Submissions
Clients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device. While testing requirements are easy to determine for some devices, other devices require intensive research.
A Problem (and a Solution) with MIL-STD-461F/G CS114 Below 10 kHz
Ten years ago, MIL-STD-461F added a low frequency extension to CS114 that models common mode noise generated by dc power systems used on Navy ships.
Human-Body Model and Electrostatic Discharge (ESD) Tests
Consider a spherical capacitor consisting of two concentric, conducive spheres separated by a dielectric.
Parasitic Oscillations and EMI Emissions
Parasitic oscillations are one of the four typical causes for emissions in EMI/EMC problems. Try to reduce the gain or break the feedback and the problem could be solved at low cost.
Derivation of Ground Impedance
Did you ever wonder why we use 0.1 ohm (and sometimes 0.5 ohm) for the ground impedance value for plug-and-socket connected equipment?