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Whitepapers



Our whitepapers allow you to dig deeper into topics and understand the science behind our services, as well as ways we can help solve your business challenges.



February 14, 2022

Cytotoxicity Failure – What Now?

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Cytotoxicity endpoint is marked for all medical devices that contact the patient/user, regardless of type or duration of contact. A...

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December 4, 2021

Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges

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Large-volume parenteral (LVP) applications are characterized by high-volume doses of a drug product, which are administered intravenously. Flexible-bag systems, which...

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July 12, 2021

Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

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The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic...

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January 20, 2021

Disinfection Validation: How to Classify and Validate Your Medical Device Disinfection Process

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Medical device reprocessing, and the scientific validation of reprocessing instructions, are critical steps to ensuring devices are safe and effective...

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January 5, 2021

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

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In October 2020 FDA released a new draft biocompatibility guidance document which focuses on the biological evaluation of devices in...

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