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Reprocessing Implants: Challenges for Validation

Implant caddies or similar implant storage units for single use implants are commonly opened and exposed during surgical procedures. What...

Calculation of the Duration of Exposure and Associated Biological Effects for Biocompatibility Evaluation

In the biocompatibility assessment of medical devices, two of the primary points of consideration are how long a device contacts...

End-to-End Human Factors for Medical Devices and Reprocessing Usability Testing

Human factors engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and effective in real-world...

Fundamentals of Disinfectant Efficacy

Disinfectants must be qualified on the surfaces present within a pharmaceutical manufacturing environment before they are approved for use in...

Accelerating Product Release Through Patent-Pending RapidCert™ Biological Indicator (BI) Sterility Testing

RapidCert™ BI testing offers a transformative approach to biological indicator testing, delivering faster results than traditional compendial methods—incubation time is...