Search Results for 'verification testing'
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Survival Tips for Third-Party Verification
I have spent much of my career helping companies resolve significant regulatory issues, mostly those emanating from the U.S. Food and Drug Administration (FDA). I’m not really sure why I’m drawn to these administrative struggles; perhaps…James A. Dunning, Principal, QPC Services LLC 03.07.19
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Software & IT
Software Validation: How It Should Be Done
With vague guidance from FDA, device makers need to ensure they are using best practices.Online Exclusives Erin Wright, Validation Product Manager, MasterControl 04.26.18
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Diagnostics | Surgical
Swab Test Verifies Endoscope Cleanliness in 15 Seconds
Hygiena’s new SuperSnap testing system offers simple and dependable detection of ATP.Hygiena 07.25.17
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Verification Matters
At one time or another, many of us have asked ourselves, “Why verify?” We verify/inspect and routinely find no defects or noncompliances. In my case—and I assume for most others—the feeling is fleeting. Verification serves a d…James A. Dunning, Owner, QPC Services, LLC 03.07.17
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Contract Manufacturing | R&D & Design | Testing | Tubing & Extrusion
8 Considerations Prior to Nitinol Implant Design
The nickel and titanium alloy offers advantages for medtech, but questions first need to be answered.Online Exclusives Norman Noble 04.08.16
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Contract Manufacturing | Materials | Molding | R&D & Design | Testing
How Do Good Laboratory Practice Regulations Apply to Medical Devices?
Industry consultants provide a primer on the use of GLP in medtech.Aaron Burke, Pacific BioLabs 09.11.14
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Contract Manufacturing | Molding | R&D & Design | Testing
The Philosophy of Process Validation
Validation is not about a set of hard and fast rules—it’s about organically understanding a process and approaching process control with finesse.Ranica Arrowsmith, Associate Editor 09.10.13
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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
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Contract Manufacturing | Materials | Molding | R&D & Design | Software & IT | Testing
Contract Testing Services and Equipment Directory
The following directory lists suppliers who provide contract testing services and equipment to the medical device industry.12.21.05
