Naomi Schwartz | Source | Senior Director - Cybersecurity Quality & Safety at MedCrypt
Naomi Schwartz
Senior Director - Cybersecurity Quality & Safety at MedCrypt
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Naomi is the Senior Director of Cybersecurity Quality and Safety at MedCrypt. She has over 20 years of systems engineering experience, including over 6 years of medical device evaluation and postmarket event response while at FDA. Naomi engages with medical device manufacturers to optimize their cybersecurity framework to meet regulatory requirements and guidelines.
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Until the omnibus passed, FDA had no statutory authority to ask for cybersecurity. All cybersecurity requests were previously framed within a risk management context.
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Key Ways to Prepare For Revamped Medical Device Security Requirements
Medical device manufacturers will have to adjust their premarket activities to prepare for Oct. 1st, when the FDA will begin refusing medical device submissions for cybersecurity reasons.
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MedCrypt (https://medcrypt.com/index.html)
Senior Director - Cybersecurity Quality & Safety
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