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

1-3 September 2021 | SWEECC H2&H4

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Quality Control

2020.09.10
7 Things to Consider When Using a Medical Device Contract Packager
While economics often factor into the decision to enlist a contract packager, there are several other aspects medical device companies must consider..........



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2020.08.24
Managing Testing Strategies Under the EU MDR
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.......



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2020.08.21
Proposed Medical Devices Standard Will Help Validate Cleaning Methods
An ASTM committee is developing a series of guides for validating cleaning instructions for medical devices.......
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2020.08.20
4 Steps for Error-Free Coding on Pharmaceutical Packages
Validation is a major component of pharmaceutical manufacturing, ranging from production systems, packaging equipment, and computer programs. The packaging printer is a critical element in the validation process......



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2020.08.12
Exceeding regulatory requirements: Beyond the checklist

Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks.



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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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