Want to hear expert thoughts on the MedTech overview and industry pain points? Check out our first ‘Cybersecurity Talks’ podcast now! The post [Podcast #1] Cybersecurity meets MedTech: Unveiling our new podcast ‘Cybersecurity Talks’ appeared first on Irdeto Insights ..read more

Let's explore a detailed explanation of the Periodic Safety Update Report (PSUR), a component of the post-market surveillance system, and discuss how tailored vulnerability management for MedTech can enhance this crucial area of compliance with the medical device regulation. The post Understanding cybersecurity’s role in the PSUR: Unpacking EU medical device mandates appeared first on Irdeto Insights ..read more

Attaining NIS2 compliance is a standard process that requires around 12 months for completion. With non-compliance carrying severe penalties, it’s crucial for businesses, particularly MDMs, to pay attention to the essential components of this Directive, prepare adequately and act before the approaching deadline arrives. Check out our compliance checklist and actionable steps for MDMs and see how well-prepared your business is The post NIS2: One year to go   appeared first on Irdeto Insights ..read more

How has the medical device regulatory landscape evolved in recent years and how do MDMs cope with the changes? The insightful discussion between Irdeto's and QBD Group's experts will provide all you need to know. The post Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto  appeared first on Irdeto Insights ..read more

The healthcare industry has made great efforts over the past few years to prevent and mitigate the risks of cyberattacks targeting connected medical devices and healthcare systems. The alarming numbers indicating an increase in cyberattacks against healthcare institutions sadly show that there are still problems to tackle, particularly on the part of MDMs. The introduction of the NIS2 Directive marks one of the latest and most important attempts to address these challenges. What's the meaning of NIS2 to the healthcare sector and how do MDMs get started? The post The implication of NIS2 on the ..read more

A number of regulations have been put in place to help fortify medical devices and their manufacturing lines against potential attack patterns, including the revised Directive on the Security of Network and Information Systems (NIS2 Directive). The introduction of NIS2 will help form a better coordinated basis for cybersecurity action. Here's what you need to know about it. The post Network Information Systems Security (NIS2) 101  appeared first on Irdeto Insights ..read more

A Coordinated Vulnerability Disclosure (CVD) refers to a specific structured process where vulnerabilities are reported to organizations in a manner that allows for diagnosis and remediation before released to third parties or the public. CVD comprises of the coordination between the reporting entities and organizations with particular regard to the timing for both the remediation and publication of vulnerabilities. This blog post will explore the basics of CVD and what you need to be aware of. The post Coordinated Vulnerability Disclosure (CVD) 101  appeared first on Irdeto Insights ..read more

Software Bill of Materials (SBOM) and Vulnerability Exploitability eXchange (VEX) are becoming essential components of medical device cybersecurity. The effectiveness of medical device security practice, however, can be challenging to accomplish without first understanding how VEX complements an SBOM throughout the product lifecycle. Let's explore how to make the best use of these two concepts in this article. The post SBOM and VEX help you complete your medical device risk assessment with ease  appeared first on Irdeto Insights ..read more

Threat modeling, in recent years has come to take center stage in the world of healthcare cybersecurity. The FDA has been helping medical device manufacturers ramp-up their skills in this field, however it still remains a complex task to perform for newer manufacturers. Let's explore the challenges, current state of practice and the right approach. The post The importance of threat modeling for small Medical Device Manufacturers  appeared first on Irdeto Insights ..read more

To secure against potential cybersecurity vulnerabilities, Medical Device Manufacturers (MDMs) should enroll their medical devices into a Public Key Infrastructure (PKI), a trusted and widely used cryptographic practice that ensures operational safety. Learn more about securing your medical device with a PKI from our free e-book: “Why should Medical Device Manufacturers (MDMs) secure their devices with a Public Key Infrastructure (PKI)?” The post How can Public Key Infrastructure (PKI) help secure your medical devices?   appeared first on Irdeto Insights ..read more