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Medical devices are becoming more interconnected leading to safer, more effective technologies enabling vulnerabilities to manifest that if exploited threaten the health and safety of patients. The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet and network connected devices.
Recent cybersecurity incidents, including ransomware, have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities. Such incidents may lead to patient harm thru delays and/or errors in diagnoses and/or treatment.
This webinar will delineate FDA’s efforts at assessing the landscape including:
The US FDA has retired its QSIT (Quality System Inspection Technique) requirements for medical devices…
Webinar Part 1 The regulatory foundation and rationale behind the QSMR role FAQs on QSMR…
This Advanced Compliance Writing Webinar will teach you how to draft responses to enforcement actions,…
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