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.

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.
article placeholder

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?