Radiopacity

Radiopacity refers to the relative inability of electromagnetic radiation, specifically x-rays, to pass through a particular material....

Radial Force

Radial force testing is used to determine the stiffness (hoop strength) of a medical device when placed...

MR Safety Evaluation of Orthopedic Devices: Why it’s important and how to select test device configuration

It is important to evaluate orthopedic devices to ensure patient safety. An MR Safe device is  nonmagnetic,...

OMTEC 2015: Design Verification Testing: What should you do when a testing standard doesn’t exist?

Test methods are critical to success of design verification and validation. Many medical device industries (e.g., cardiovascular)...

Anatomic Modeling

Challenges and Benefits Accurate modeling of normal anatomy as well as of morphologic changes caused by disease...

Are slender devices with low electrical conductivity unlikely to exhibit RF-inducing heating?

Are slender devices with low electrical conductivity unlikely to exhibit RF-induced heating? This publication evaluates representative generic...

Draft Guidance Sheds Much Needed Light On MRI-Compatibility

Electrical Conductivity

Many medical devices are primarily nonmetallic, but do have minimal electrical conductivity (for example, a plastic stent...

MD&M West 2014: What do you do when regulatory requirements exceed that of reasonable engineering controls?

We all have the same goal: a safe medical device. Occasionally, the regulatory and company requirements are...

MD&M West 2015: MRI safety evaluation and labeling of passive implants: Meeting the need with virtual and physical test capabilities.

We have developed virtual and physical test capabilities for MR safety evaluation of passive devices. We can...

MD&M West 2016: Design Verification Testing: What should you do when a testing standard doesn’t exist?

It is important to be active in Standards Development when you need to publish a new standardized...

In Vivo and In Vitro Nitinol Corrosion Properties

Regulatory authorities often require in vitro testing on medical devices prior to approval. Current standardized corrosion testing...