FALLS CHURCH, Va. (PRWEB)
Július 19, 2022
Medical Device Cybersecurity
Understand the Latest Developments
FDAnews webinárium
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.
A webinárium részletei
Medical Device Cybersecurity
Understand the Latest Developments
FDAnews webinárium
Tuesday, Aug. 2, 2022, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/medical-device-cybersecurity-08-02-22
Oktatás:
$287
Easy Ways to Order:
Online: https://wcg.swoogo.com/medical-device-cybersecurity-08-02-22
Telefonon: 888.838.5578 vagy 703.538.7600
Az FDAnews-ról:
Az FDAnews a hazai és nemzetközi szabályozási, jogalkotási és üzleti hírek és információk vezető szolgáltatója az Egyesült Államok FDA és az Európai Gyógyszerügynökség által szabályozott iparágakban. A gyógyszerészeti és orvostechnikai eszközökkel foglalkozó szakemberek az FDAnews nyomtatott és elektronikus hírleveleire, könyveire és konferenciáira támaszkodnak, hogy megfeleljenek a nemzetközi szabványoknak és az FDA összetett és folyamatosan változó előírásainak.
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