FALLS CHURCH, Va. (PRWEB)
July 19, 2022
Medical Device Cybersecurity
Understand the Latest Developments
An FDAnews Webinar
Tuesday, Aug. 2, 2022, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/medical-device-cybersecurity-08-02-22
If medical devices are connected to networks, other devices or the internet, they’re vulnerable to attacks that can impact their safety and effectiveness.
The U.S. Department of Health and Human Services listed medical devices as one of the top five cybersecurity threats and the FDA is pushing manufacturers on cybersecurity.
This webinar will show attendees how to incorporate cybersecurity into their quality system and defend it to interested third parties: to stay compliant, bolster device defenses and protect patients, not to mention stay out of security breach-related headlines.
Eric Henry, a senior quality systems and compliance advisor in the FDA and Life Sciences practice of the law firm King & Spalding, will explain how to bolster medical device cybersecurity. He’ll address the defense of cybersecurity during facility inspections and product submissions in light of the latest regulatory activities, including:
- How cybersecurity relates to design controls and the quality system more generally
- Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts
- How addressing cybersecurity risk relates to product risk management
- What regulatory literature currently exists globally and some of the ways they compare to each other (e.g., FDA premarket and postmarket cybersecurity guidances, AAMI TIR-57 and TIR-97, IMDRF cybersecurity guidance, MDCG cybersecurity guidance, and various national guidance documents)
- Common cybersecurity issues identified during inspections and submission reviews
Ensure devices can withstand attack, keep patients safe and make sure devicemakers’ businesses aren’t a part of the next hack-related headline.
Webinar Details
Medical Device Cybersecurity
Understand the Latest Developments
An FDAnews Webinar
Tuesday, Aug. 2, 2022, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/medical-device-cybersecurity-08-02-22
Tuition:
$287
Easy Ways to Order:
Online: https://wcg.swoogo.com/medical-device-cybersecurity-08-02-22
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.
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