|
|
|
By Naveen Agarwal, Ph.D., Creative Analytics Solutions, LLC
Identification of hazards, hazardous situations, and harms is foundational to analyzing the risks associated with a medical device. Yet, these terms are often misunderstood and misapplied. This first part of a three-part video series reviews the term “hazard” in detail, highlights areas of confusion, and illustrates a few examples to facilitate a better understanding and its application in risk analysis.
|
|
By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.
|
|
|
Poster
|
By Christopher J Rini, MS; Rick Klug, AAS; Aishwarya Vaidyanathan, MS; Bruce Roberts, BS; Didier R Morel, Ph.D.; Ronald J Pettis, Ph.D.,
BD Medical - Pharmaceutical Systems
High-volume parenteral delivery systems require consideration of both functional design and human factors to enable successful, consistent, and reliable delivery to the target tissue. The purpose of this study was to examine the influence of needle inner diameter and length on delivery time across a range of fluid viscosities using a prototype auto-injector device.
|
|
Article
|
Protolabs, Inc.
Combining the sense of smell with rapidly evolving virtual reality (VR) technology — enabling medical applications, including those that help soldiers with post-traumatic stress disorder (PTSD) — is the mission of OVR Technology, a startup in Burlington, VT.
|
|
Article
|
B. Braun OEM Division
Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations.
|
|
White Paper
|
HID Global
With thousands of RFID tag configurations to choose from, and new ones introduced almost daily, what is the best way to sort through the sea of passive transponders to find cost-effective tags that will deliver optimal performance for each application? This white paper presents seven items to consider when choosing the right RFID tag for any task.
|
|
White Paper
|
MTD Micro Molding
Precise miniature plastic parts are the result of exact tooling processes such as micro-tooling and micro-injection molding. By understanding the tolerances of these tooling processes, it’s possible to achieve repeatability and part accuracy for even the most advanced micro medical device.
|
|
Q&A
|
Evonik Corporation
In this interview with Balaji Prabhu, from Evonik’s Medical Device Competence Center in the U.S., we review how medical device companies can best evaluate current biomaterial options for the four leading 3-D printing technologies.
|
|
Video
|
DSM Biomedical
In this video, Gino Bradica, Ph.D., director of technical support, and Jens Thies, Ph.D., senior science fellow, discuss how DSM is treating heart disease with its biostable and biocompatible polyurethanes and its high-strength and low-profile ultra-high-molecular weight polyethylene (UHMWPE) fibers. These unique biomaterials offer sustainable solutions for the design of the next generation of heart valve replacements.
|
|
|
Knowles Precision Devices DLI
|
|
SCHOTT North America Inc.
|
|
|
Connect With Med Device Online:
|
|
|
|
|
|
|
|