Testing

Assessing Hemocompatibility for Medical Devices in Contact with Circulating Blood

Have you considered the risks of hemolysis and thrombosis as well as the impact of any changes in manufacturing and processing parameters?

Chemistry for Toxicological Risk Assessment—Transitions in Expected Approach

FDA's expectations regarding ChemTox will be discussed during an upcoming MD&M West 2020 presentation.

7 Considerations for Choosing a Testing Partner

Expectations for medical device testing are changing, thanks to evolving regulations and standards as well as other factors. Finding the right testing partner is critical for success, so here are a few points to consider.

Implementing the IEC 60601-1 Medical Electrical Equipment Standard

Why a mobility classification matters and how to choose the right one.

The Pros and Cons of Standardized Testing

Is a standard test necessarily the right test?

Is Your Testing Program Ready for the EU MDRs?

The new EU regulations will require much more documentation and perhaps some new evaluations from medical device manufacturers. An expert explains how to perform a gap analysis and begin preparing now for May 2020.

Another Reason to Update Your Biocompatibility Approach: EU MDRs

A chemist and biocompatibility expert offers the latest insights and predictions on medtech biocompatibility testing.

SyncThink Goes for Magic Leap to Get into AR

The Palo Alto, CA-based company will collaborate with Magic Leap, a specialist in augmented reality and spatial computer technology to bring its technology to an AR platform.

ArcherDx Seeking Broader Reach for Cancer Diagnostic

The Boulder, CO-based company has been granted a Breakthrough Device Designation for its liquid biopsy and tissue specimen assay.

New Study Finds Discrepancies in Cervical Cancer Screening Rates

A study from Mayo Clinic researchers shows less than two thirds of women ages 30 to 65 were up-to-date with cervical cancer screenings in 2016, which is below the 81% screening compliance rate self-reported in the 2015 National Health Interview Survey.