2021.04.27
Understanding Regulatory Expectations for Combination Products
Experts from WuXi AppTec Medical Device Testing answer a few questions about submitting combination products for regulatory approval......



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2021.03.18
Understanding ASTM’s New Specification for Barrier Face Coverings
ASTM has published F3502-21, a standard specification for general-purpose face coverings, which could help consumers understand covering filtration efficiency and more......



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2021.01.13
Quality Considerations for Drug-Device Combination Products
Understanding the GMP requirements of each component is critical to product and compliance success.......



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2021.01.12
Compliance Is Compulsory, and Product Labeling Is No Exception
For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations”......



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2021.01.07
Using Appropriate Controls to De-Risk Medical Devices
Strong engineering principles and a strong clinical understanding are of the utmost importance when considering potential failure modes, said a Virtual Engineering Week speaker......



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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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