Connected medical devices offer benefits but also pose cybersecurity risks that can disrupt patient care. The FDA’s new guidance highlights the need for strong cybersecurity measures and provides recommendations for integrating these measures into human factors engineering to ensure device safety.
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Patrick McCormack
Director
Patrick has 10 years of experience applying HFE/UE to the development of medical devices with an emphasis on ensuring safe and effective use as part of the FDA approval process. He possesses expertise in the interpretation and implementation of various design standards, including IEC 62366, AAMI HE75, BS EN ISO 14971, and others. Patrick has a BS in Human Factors Psychology from Embry-Riddle Aeronautical University.



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