Don’t Sell Me a Lemon with a Virus! with Aftin Ross, Senior Special Advisor for Emerging Initiatives at the FDA, Chris Reed, Director of Regulatory Policy, Digital Health and Product Security at Medtronic, and Debra Bruemmer, Sr. Manager Mayo Clinic
Outcomes Rocket
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Is the Joint Security Plan Required by the FDA?
Having clarity there is key and a proper guidance could be a huge benefit. So certainly if you have good security and you can articulate that in your engagements with the agency, that can certainly help you as you are going through your pre-market process.
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