Incorporating Medical Device Risk Management into QMS Protocol

5 Tips for Choosing a Reliable Testing Partner for Regulatory Success

Follow these tips when searching for the right third-party testing partner to avoid delays and ensure your product’s smooth journey to market.

How Does Proactive Equipment Maintenance Improve Medical Product Quality?

How Does Proactive Equipment Maintenance Improve Medical Product Quality?

UDI at 10: Moving into The Future

This article presents a snapshot of the current state of the UDI and how the movement may evolve.

Seeing Double: What to Watch When Bringing Combination Products to the EU Market

What You Need to Know About USP 661 Series on Plastic Packaging

The USP-NF is a combination of two compendia: the United States Pharmacopeia (USP) and the National Formulary (NF). When USP-NF set out to revise General Chapter <661>, Containers-Plastics in 2013 [published in Pharmacopeial Forum/PF 39(5)], one stated goal was to increase flexibility by going from prescribed tests and limits to a model where the drug manufacturer could apply tests based on risks associated with the packaging’s Materials of Construction (MoC) and the drug product dosage form.

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.”