Search Results for 'testing'

Buyers Guide Companies

View All Buyers Guide Companies »

Buyers Guide Categories

View All Categories »

• 

  Keeping Compliance on Track Through Testing

  The beginning of 2020 has left the industry strained and delayed implementation of the Medical Device Regulation by one year.

  Sandi Schaible, WuXi Medical Device Testing 05.01.20
  

  ---

• Diagnostics
  

  Siemens Healthineers to Expand SARS-CoV-2 Testing

  With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.

  Siemens Healthineers 04.23.20
  

  ---

• 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
  

  ---

• Packaging & Sterilization
  

  Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

  With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package desi…

  Britt Jones, Manager of Package Testing Services, WuXi AppTec 06.13.19
  

  ---

• Cardiovascular | Neurological | Surgical | Testing
  

  Active Implantable Medical Device Testing: What You Need to Know

  Both the implanted product and non-implantable supporting equipment require testing and evaluation to specific standards.

  Online Exclusives William Stearns, Associate Senior Engineer, Intertek 08.13.18
  

  ---

• Testing
  

  Extractable/Leachable Chemistry Testing Strategies for Medical Devices

  It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessmen…

  Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS 04.03.17
  

  ---

• R&D & Design | Testing
  

  5 Considerations for Human Factors Testing

  When developing a device, the way it will be used, who uses it, and where it’s used are all critical factors to consider.

  Online Exclusives Kady Harper, Technical Writer 09.13.16
  

  ---

• Packaging & Sterilization | Testing
  

  Functionality vs. Simulated-Use Testing in Device Reprocessing

  A brief look at functionality vs. simulated-use testing for processing and reprocessing of reusable scopes and medical devices.

  Online Exclusives Emily Mitzel, Alpa Patel & Nick Workman, Nelson Laboratories, Contributing Columnists 09.11.14
  

  ---

• Contract Manufacturing | Materials | R&D & Design | Testing | Tubing & Extrusion
  

  Testing the Medical Device Testers

  A host of new and upcoming compliance requirements not only pose a challenge for medical device makers, but to their contract testing partners as well.

  Mark Crawford, Contributing Writer 03.13.14
  

  ---