Search Results for 'testing'
Buyers Guide Companies
Microsite Companies
Featured Companies
View All Buyers Guide Companies »
Buyers Guide Categories
View All Categories »
-
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
-
Testing
Why Big Companies With Internal Labs Should Outsource Testing
Most of us know when we’ve hit that line signaling we’ve left our cutting edge and officially spread ourselves too thin. Pushing to do and be more is often a half-step from maxing out and dropping all those balls we’re juggling.…Dawn A. Lissy, President & Founder, Empirical 03.07.19
-
Diagnostics
FDA Grants Breakthrough Device Designation to Siemens Healthineers’ ELF Test
The company is collaborating with Gilead Sciences as part of its work to seek clearance of the test.Siemens Healthineers 11.09.18
-
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
The Value of (Outside) Evaluation: Outsourcing Testing Services
Testing service and equipment providers are challenged to stay abreast of regulatory guidelines.Sam Brusco, Associate Editor 03.15.18
-
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
-
Cardiovascular | Contract Manufacturing | Materials | R&D & Design | Testing | Tubing & Extrusion
Constantly Tested
Testing providers need to stay ahead of regulatory, material and manufacturing trends to consistently meet the needs of medical device firms.Mark Crawford, Contributing Writer 03.11.15
-
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 | R&D & Design | Software & IT | Testing
Validating Medical Device Software Includes and Goes Beyond Testing
Validating Medical Device Software Includes and Goes Beyond Testing David A. Vogel, PhD, is president of Intertech Engineering Associates, Inc. in Norwood, Massachusetts. Intertech is an outsourced engineering service provider to…David Vogel 02.27.06
