Not all EMC emissions look alike — and knowing the difference can save your compliance test. Kenneth Wyatt breaks down how to use near-field probes to identify and interpret broadband versus narrowband emission profiles, so you can trace noise back to its source before it becomes a costly failure.
The post EMC Bench Notes: Interpreting Emissions Using a Near-Field Probe appeared first on In Compliance Magazine.
The FDA has updated its list of more than 1,700 recognized voluntary consensus standards used to demonstrate compliance in medical device premarket submissions. Find out which specialties are covered and how declarations of conformity can streamline your path to market authorization.
The post FDA Updates List of Recognized Consensus Standards appeared first on In Compliance Magazine.
The FDA has finalized its guidance on human factors information required in medical device marketing submissions, outlining a risk-based framework for 510(k)s, PMAs, De Novo requests, and HDE applications. Here's what manufacturers need to know before their next premarket submission.
The post FDA Releases Guidance Document on Human Factors Information in Marketing Submissions appeared first on In Compliance Magazine.