Regulatory Insights: The Future of MedTech and Pharma Under the New Administration
The new presidential administration in the United States could significantly impact MedTech and pharmaceutical regulations for manufacturers...
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2023 Spring AAMI Standards Week Update
In this podcast from Nelson Labs, business leaders who recently returned from the AAMI standards week meetings...
Is it time to Re-Evaluate your Design History File for Reusable Device Validations
Standards for reprocessing have become a top priority for regulatory bodies worldwide. The active work around reusable...
Reprocessing Validations Flexible Endoscopes and AAMI ST91
The newly revised AAMI ST91:2021 standard provides comprehensive guidelines for the processing of flexible and semi-rigid endoscopes...
Lessons from the Lab
This eBook, created in partnership with Medical Products Outsourcing Magazine, addresses common challenges and best practices for...
What is Changing in the Realm of Validations Regarding Reusable Devices?
Over the past decade, regulatory agencies have increasingly tightened requirements regarding reprocessing validations for reusable medical devices....
Reusable Advices For Reusable Medical Devices
Ensuring that reusable medical devices can be properly cleaned, disinfected, and sterilized is crucial for patient safety...
Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)
The cleaning, disinfection, and sterilization of medical devices are critical processes that ensure patient safety and device...
Decontamination, Sterile Processing, and Performance Testing of Personal Protective Equipment (PPE)
During the COVID-19 pandemic, the demand for personal protective equipment (PPE), especially medical face masks and respirators,...
Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)
Throughout the COVID-19 crisis, there has been a significant emphasis on rapidly bringing critical products to the...