PRESENTER: DENIS DMITRENKO
Cybersecurity Requirements
for FDA 510(k)
for FDA 510(k)
This meeting will focus on understanding the cybersecurity requirements for FDA 510(k) submissions (eSTAR). We will discuss key guidelines, documentation needs, and best practices to ensure medical devices meet FDA standards for cybersecurity. Topics include premarket submission expectations, addressing threats and vulnerabilities, and creating effective cybersecurity documentation. Ideal for teams preparing for regulatory submissions or enhancing device security.
WHAT YOU WILL LEARN
FDA 510(k) cybersecurity documentation essentials (eSTAR), best practices for secure medical devices and preparation for the cybersecurity testing for:
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Medical DevicesPenetration testing for Software as a Medical Device and Medical Devices that include Software -
Wearables & IoTPenetration testing for Wearable and IoT networked Medical Devices and threats validation -
Source CodeBinary, dependencies, and source code analysis for security breaches -
Cloud InfrastructureCloud infrastructure and backend security assessment -
Risk AssessmentCyber security risk assessment compliant with FDA, TGA and EU MDR requirements -
Tech DesignA gap assessment for your technical design and dataflows
THIS SESSION IS FOR
THIS SESSION IS FOR
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RA&QA ProfessionalsRegulatory and Quality Assurance Professionals -
Regulatory AdvisorsPrivate consultants and RA firms -
DevelopersMedical Device Manufacturers, Developers and Designers -
Cybersecurity ProfessionalsCybersecurity Engineers, Cybersecurity Consultants and Testers
REGISTER
The session instructions will be sent to your email after registration. The registration fee is $50 AUD (incl. GST).
*Our past and present clients can attend this session free of charge.
