The Role of EPSS in Prioritizing IoMT Security Threats

The Exploit Prediction Scoring System (EPSS) can help healthcare organizations prioritize security vulnerabilities, but it has limitations in IoMT environments. While EPSS provides valuable data-driven prioritization, it should be combined with other risk assessments, cybersecurity frameworks, and strategies to more comprehensively secure healthcare systems’ IoMT devices.

The Importance of USP Class VI Testing

How Does Proactive Equipment Maintenance Improve Medical Product Quality?

Proactive equipment maintenance is crucial in the medical equipment manufacturing industry because it ensures the safety of the patients relying on medical products. Regularly inspecting and servicing your medical manufacturing equipment helps identify potential issues before they become major problems, preventing costly repairs, downtime, and even product recalls.

Don’t Let the EU MDR Transition Delay Fool You

A recent timeline shift for the European Union’s Medical Device Regulation (EU MDR) has created what one regulatory expert is calling, “The Great Misunderstanding of the MDR Amendment.”

A Combined Effort for Drug Delivery & Combo Product Technology

The annual Combination Products Summit focuses on solutions for the dynamic drug delivery/combination products industry with evolving regulations.

Don’t Fear the Audit: Benefits of Good Quality Practices

Quality is a loaded word. For the general public, it connotes excellence, value, worth—all of which we strive for in our business. But for some in the medical device industry, it’s about bureaucracy, liability, and conflict. Maintaining a quality management system (QMS) per the expectations of regulatory bodies can be time-consuming, confusing, expensive, and tedious.

Study Suggests Increased Number of PMA Supplements Increase Recall Risk

a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall.

Beware of Defective Medical Device Packaging

An FDA safety communication issued Thursday serves as a reminder that medical device packaging plays a critical role in the lifecycle of the device itself.

CMS Delves into Expanding Access for Emerging Technologies

The agency said it would work in the coming months to explore policy options…….

5 Strategies for Managing Medical Product Supply Chain Uncertainty

Utilizing real-time data to deliver customers’ orders on time—while ensuring quality and maintaining margins……