Testing

Testing

Going Beyond the Regulations to Evaluate Relevant Medical Device Risk

Companies need to review their testing plan so it supports a successful submission, saves time, and ensures the long-term success of their product.

Sherry Parker, Ph.D., Senior Director of Regulatory Toxicology, WuXi AppTec Medical Device Testing 06.04.20

Testing

EnMed MicroAnalytics

Victoria Tan, Marketing Assistant 04.26.20

Surgical | Testing

Medical Robots: Assessing Safety and Performance in a Growing Field

Be aware of potential hazards robots may present and testing options to address them.

Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20

Testing

Plastikos and Plastikos Medical Implements ISO 14698

This system is dedicated to test for bio-contamination, and evaluate microbiological data.

Plastikos 04.01.20

Testing

Testing in Flux: Changing Protocols for a Transformative Industry

As regulations and requirements around the world change, so too do the testing protocols for medical devices, sending OEMs to consult expert partners.

Mark Crawford, Contributing Writer 03.04.20

Testing

The Importance of Usability/Human Factors Testing

When is the work of human factors over, and how does your team know they are prepared for summative testing?

Maria Shepherd, President and Founder, Medi-Vantage 03.04.20

Materials | Testing

Particle Particulars: Why this Analysis Is Foundational for Successful Devices

In the mid-2000s, medical device experts were hopeful they’d found one solution to longer-lasting implants.

Dawn A. Lissy, President & Founder, Empirical 03.04.20

Testing

Mike on Medtech: Human Factors/Usability, Part 2

Mike Drues and Sean Fenske discuss the implications of not meeting with the FDA’s requirements for human factors testing.

Sean Fenske, Editor-in-Chief 02.03.20

Testing

Mike on Medtech: Human Factors/Usability, Part 1

Mike Drues and Sean Fenske discuss the importance of human factors within the regulatory landscape and how it came to matter to FDA.

Sean Fenske, Editor-in-Chief 02.03.20

R&D & Design | Testing

FDA Guidelines for Employing X-ray Inspection in Medical Device Development

Different materials exhibit different radiopacity as a function of material composition (i.e. atomic weight) and thickness.

Gil Zweig, President, Glenbrook Technologies 01.29.20

Testing

Managing Risks for Medical Devices: A Guide to Understanding ISO 14971

The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices.

Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Labs 10.08.19

Testing

Preparing for MDR: Test In-House or Outsource?

As the EU MDR deadline draws near, manufacturers are under pressure to bring products into compliance and get submissions in front of regulators ASAP.

Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi Medical Device Testing 10.08.19

Materials | Testing

Understanding Food-Grade vs. Biocompatibility for Medical Device Materials

Just because a material is food-safe in no way implies it is also biocompatible.

Online Exclusives Dana Trousil, Medical NPI Team Lead, StarFish Medical 08.13.19

Diagnostics | R&D & Design | Testing

ClearCut Medical Appoints President & CEO

Jim Buck brings experience in developing and commercializing new technologies.

PRNewswire 07.17.19

R&D & Design | Surgical | Testing

New Technology May Lead to Implantable Artificial Kidneys

Kidney researchers develop pioneering breakthrough in blood purification.

PR Newswire 07.09.19

Testing

Automated Assembly with The Arthur G. Russell Company at ATX East

William Mis of The Arthur G. Russell Company talks about the company's high-speed assembly and test systems for disposable medical devices.

Videos Sam Brusco, Associate Editor

Testing

Laboratory Testing with Nelson Labs at BIOMEDevice Boston

Dr. Matt Jorgensen discusses the company’s new analytical chemistry approaches and how it’s preparing for the EU’s MDR deadline.

Videos Sean Fenske, Editor-in-Chief

Electronics | Packaging & Sterilization | Testing

Transporting Lithium Batteries Used in Medical Devices

What you need to know about the UN 38.3 standard.

Online Exclusives Rick Byczek, Global Director of Transportation Technologies, Intertek 04.16.19

Machining & Laser Processing | Testing

New Technique Reduces Latency Between Machining and Measurement

The technique calculates how long it takes for a component's temperature to be stabilized so that it can safely be measured by a coordinate measuring machine.

University of Huddersfield 03.29.19

Materials | R&D & Design | Testing | Tubing & Extrusion