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R&D & Design | Software & IT | Testing
Transformative Testing: Addressing Patient Safety and Cybersecurity
With changing regulatory landscapes and requirements, testing providers are being asked to do more in terms of ensuring the safety of medical devices.Mark Crawford, Contributing Writer 03.07.19
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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
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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
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Digital Health | Electronics | Software & IT | Testing
Coexistence Testing for Wireless Medical Devices: A Guide to Ensuring Reliable Systems
With mobile medtech in healthcare facilities and the home, OEMs must ensure interference is not a cause for concern.Online Exclusives Ashton Hainge, Consultant, Intertek 08.02.17
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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
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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
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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
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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
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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
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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
