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.

Test and Measurement: Regulatory Updates and Strategic Implications

Medical device companies are operating in a climate of rapid transformation. The traditional regulatory and testing frameworks that have guided development for decades are evolving, prompted by technological innovation, increased globalization, and lessons learned during recent public health challenges.

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

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.