2020.06.15
Medical Device Extractables and Leachables Testing in 2020

Chemistry for toxicology (ChemTox) testing has evolved considerably in the last couple years. Here’s what you should consider for your own program.



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2020.04.16
How to navigate testing for devices that use wireless technology

The Federal Communications Commission (FCC) has a different testing requirements for wireless medical devices than the FDA. Here are some tips of choosing a testing method for FCC compliance.



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2019.07.18
Implementing the IEC 60601-1 Medical Electrical Equipment Standard
Why a mobility classification matters and how to choose the right one.



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2019.07.10
The Pros and Cons of Standardized Testing
Is a standard test necessarily the right test?



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2019.02.27
Applying Quality Management Best Practices for Medtech
A look at how one medical device manufacturer automated quality management along with ideas on how shared intelligence can drive quality from the shop floor to the top floor.



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2018.03.27
Putting the ‘Management’ into Quality Management System
Three ways to demonstrate management oversight within your QMS.



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2018.03.27
IQ, OQ and PQ: The Backbone of Your Quality System
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.

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2018.03.27
Medtronic Exec: How to Move Past Compliance to Quality
The medical device industry has had a tough time recently when it comes to its reputation for addressing defects.

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2018.03.27
Philips Forced to Stop Making AEDs Until Problems are Fixed
FDA and Philips reached an agreement regarding manufacturing issues involving the company's automatic external defibrillators.



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2018.03.27
Faulty Seal Blamed for Sterlimed Agilis Recall
FDA has identified the recall as a Class I, the most serious type of medical device recall.



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