中国国际医疗器械设计与制造技术展览会(Medtec China)2018

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1-3 September 2021 | SWEECC H2&H4

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Quality Control

2020.12.01
Ensuring Data Integrity and Security in Ultrasonic Welding for Medical Devices
A look at how one equipment supplier upgraded its software to build in data integrity and security safeguards.......



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2020.11.10
What will pandemic disruptions mean for EU IVDR?
Certification under the old EU In Vitro Diagnostic Directive (IVDD) cannot be grandfathered into IVDR. IVD manufacturers must start prioritizing product portfolios and conducting gap assessments now to ensure compliance by the May 2022 deadline.......



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2020.10.26
Why Should Medical Packagers Consider X-Ray Sterilization?
Learn why X-ray irradiation is being considered as an alternative method to sterilize some polymer-based medical devices, such as wound care dressings, wearables, and ostomy appliances.......



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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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