The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic Article Surveillance (EAS), Wireless Power Transfer (WPT), 5G Cellular, electrocautery, MRI, diathermy and electrosurgical devices. The technologies that these devices use are not covered under IEC 60601-1-2.
F2 Labs has developed test methods that are accepted by the FDA to demonstrate medical devices are safe in regard to Common Electromagnetic (EM) Emitters that are foreseeable in the intended use environment, and in some areas where you may not even realize that these technologies are present.
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