The MedTech Security Podcast

Aktriva LLC
  • 5.0 (1)
  • TECHNOLOGY
  • UPDATED WEEKLY

Expert review, news and discussions about developments in MedTech security world.

Episodes

  1. 6D AGO

    Understanding FDA's new Cyberdevice Inspection Guidelines

    FDA released an updated compliance manual which includes a separate section on Cybersecurity. During a domestic inspection, investigators evaluate cybersecurity by reviewing whether "cyber devices" conform to the specific statutory requirements established in Section 524B(b)(2) of the FD&C Act. This podcast walks through the impact of this on medical device manufacturers and discusses areas to be aware and prepared for.

    18 min

  2. JAN 7

    Understanding how cybersecurity weaves into FDA's new Computer Software Assurance guidance

    The U.S. Food and Drug Administration (FDA) has issued a comprehensive guidance titled “Computer Software Assurance for Production and Quality System Software“ on 23rd September 2025, which presents nonbinding recommendations for validating computers and automated data processing systems used in medical device production or within the quality system. Prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), this document establishes a risk-based framework for Computer Software Assurance (CSA)—that specifically integrates modern concepts, including cybersecurity requirements, directly into quality assurance activities. Detailed articles can be found here https://aktriva.com/articles/cybersecurity-in-quality-fdas-guidance-on-computer-software-assurance/

    12 min

  3. 08/21/2025

    Unpacking the FDA's mandate for secure medical devices

    This episode analyzes the new FDA pre-market guidance released on June 2025

    23 min
  • 3 Episodes

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Expert review, news and discussions about developments in MedTech security world.

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