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When to Re-Test

1 month 3 weeks ago

Changing enclosures, PCB layouts, component sources, or software doesn't mean the schematic changed—but it may mean your EMC certification did. This installment of Standards Practice breaks down which hardware modifications trigger the need for retesting, and why skipping it can be a costly mistake.

The post When to Re-Test appeared first on In Compliance Magazine.

Karen Burnham

FDA Finalizes Guidance on Weight-Loss Devices

1 month 3 weeks ago

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

The post FDA Finalizes Guidance on Weight-Loss Devices appeared first on In Compliance Magazine.

In Compliance