Testing

Diagnostics | Testing

GenMark Diagnostics’ ePlex RP2 Receives EUA from FDA

Provides results for more than 20 viruses and bacteria in less than two hours.

GenMark Diagnostics Inc. 10.09.20

Testing

Nelipak Facility Earns ISO/IEC 17025 Accreditation

Provides a comprehensive range of testing services to support package testing requirements.

Nelipak 09.10.20

Testing

Assessing Nanoparticles for Biocompatibility

It is important to have an appropriate testing protocol in place for this relatively new medical technology.

Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Laboratories 09.01.20

Diagnostics | Testing

Alliant Offers COVID-19 Antibody Test Kits

Allows individuals to screen for both IgG and IgM strands of the coronavirus.

Globe Newswire 07.06.20

Diagnostics | Testing

Neoteryx's Mitra Device Registered with Australian TGA

Can now be imported into Australia for use in research and clinical diagnostic applications.

PRNewswire 06.22.20

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