The MedTech Security Podcast

This briefing summarizes critical cybersecurity developments impacting the medical device industry as of July 2026. It highlights CISA advisories regarding high-severity vulnerabilities in imaging software libraries and reports on a major data breach involving Medtronic’s corporate infrastructure. Additionally, the text addresses regulatory challenges in Europe, specifically the delayed reporting...

This briefing outlines critical updates in global medical device cybersecurity regulations and standards as of June 2026. It highlights the FDA’s heightened enforcement of quality system inspections and software documentation, alongside the EU’s approaching deadlines for mandatory incident reporting under the Cyber Resilience Act. The report also details the UK’s new reliance frameworks and Austra...

Weekly Briefing: The High Stakes of MedTech Compliance and Procurement This week, we dive into the intensifying global regulatory landscape and a major shift in how hospitals buy technology. Key highlights include: FDA Enforcement & EUDAMED Deadlines: The FDA is now in full "implementation mode" for QMSR-aligned cybersecurity , with reviewers increasingly flagging submissions that lack VEX dat...

The provided briefing outlines a  volatile cybersecurity landscape  for the medical technology industry as of May 2026, characterized by  increasingly sophisticated AI-driven threats  and high-profile data breaches. Current data reveals that healthcare organizations are  tightening procurement standards , frequently rejecting vendors who fail to provide comprehensive security documentation like So...

This report from  The MITRE Corporation  outlines critical  cybersecurity risk management strategies for medical devices utilizing modern, high-tech innovations. It specifically examines the integration of  cloud computing ,  artificial intelligence and machine learning (AI/ML) , and  post-quantum cryptography (PQC)  within the healthcare sector. The text identifies unique threats, such as  data p...

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 discusse...

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 Radio...

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