中国国际医疗器械设计与制造技术展览会(Medtec China)2018

Dedicated to design & manufacturing for medical device

14-16 September 2020 | SWEECC H2&H4

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Quality Control

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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