Silicone Nanochip Can Reprogram Biological Tissue in Living Body

The noninvasive nanochip applies a harmless electric spark to deliver specific genes in a fraction of a second.

Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device...

Guide to Package Integrity & Validation Testing under ISO 11607 and MDR

Updates to ISO 11607, Parts 1 and 2, have left many medical device manufacturers wondering about the future of their packaging designs. These changes come at a stressful...

Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants

Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier...

Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1

When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe...

Software: Improving Risk Management in Medical Device Manufacturing

In an industry where people's health and wellness are on the line, manufacturers can't afford to let risk go unaddressed. As the International Organization for...

Bionic Wheelchair Breaks New Barriers

People confined to a wheelchair are still confronted with insurmountable obstacles in everyday life — even in today’s more wheelchair-accessible society. There are often no elevators in a building...

SFDC/DHR Interface Systems Add Parametric Data to Support Medical Manufacturers

In this era of ever more stringent FDA oversight and regulations, the responsibility for vigilance falls on medical manufacturers and their manufacturing...

Digital Wound Measurement and Tracking System

Historically, the subjective nature of wound treatment has lead to many trial-and-error therapies to match wounds with the right treatment. The WoundMatrix™ digital wound measurement and...