Explore the critical role of electronics cleaning validation in medical device manufacturing. Learn about regulatory requirements, contamination risks, and effective cleaning methods
Vapor degreasing emerges as a superior cleaning method for complex medical electronics, ensuring regulatory compliance.
Proper electronics cleaning validation is critical for patient safety as medical devices become increasingly miniaturized.
Structured IQ/OQ/PQ validation framework essential for medical device manufacturers facing heightened regulatory scrutiny.
Your Guide to Medical Device Sterilization: Methods, Compliance, Challenges & Trends
Sterilization has always played a central role in medical device development. But today, it’s no longer just a matter of checking a regulatory box or signing off on a quality assurance protocol. It’s a design constraint, a supply chain risk, and increasingly, a competitive differentiator. Further, a next generation of sterilization modalities are emerging.
Transformative Medical Device Testing
The medical device industry is on the brink of profound transformation, driven by breakthroughs in artificial intelligence (AI), wearables, additive manufacturing (AM), and enhanced cybersecurity. Medical device manufacturers (MDMs) are starting to embrace the integration of automation, digitization, and Internet of Things (IoT) technologies. So far in 2025, testing firms report increased interest in the end-of-life use of reusable devices, human factors testing for instructions for use (IFU), and low-temperature sterilization methods for temperature-sensitive devices.
Incorporating Medical Device Risk Management into QMS Protocol
How to improve current risk management processes, ensur […]
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.
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
Autoinjector pens, smart inhalers, syringes prefilled w […]
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
The United States Pharmacopeia (USP) group is a non-gov […]
