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Author: Lise Vanderkelen





May 24, 2022

Lessons from the Lab eBook

This eBook addresses common challenges and best practices for medical-device manufacturers with questions about testing their products. Table of Contents: EO Optimization and Potential Effects on Sterile-Barrier Packaging Patient-Specific Implants Often Require More Testing Extractable Chemical Characterization and Risk Assessment:...

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March 21, 2022

A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures

Six steps to assess the situation and determine how to move forward… Each medical device present or coming on the market needs to have a demonstrated biocompatibility to protect users from potential biological risks arising from its intended clinical use....

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February 22, 2022

Reusable Advices For Reusable Medical Devices eBook

Ensuring that reusable medical devices can be properly cleaned, disinfected, and/or sterilized is imperative to ensure patient safety and to minimize healthcare-acquired infections, corrective actions, and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about the spread of diseases,...

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December 7, 2021

Which parameters must be validated during a steam sterilization validation?

Understanding the sterility assurance level To understand how steam sterilization processes are validated, it is important to understand some key concepts about sterilization. The purpose of sterilization is to inactivate microbiological contaminants, thereby rendering products sterile[1]. The kinetics of inactivation...

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November 30, 2021

Should all Steam Sterilization Cycle Parameter Sets Indicated in your IFU be Validated?

ISO 17664:2017[1] as well as FDA[2] state that if a medical device is intended to be sterilized, at least one validated sterilization method must be specified in the IFU. Consequently, if devices are intended to be steam sterilized, at least...

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