Explore the updated standards and regulatory requirements for reusable medical devices to assist in your company’s compliance with these regulations.…
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The Different Classes of Reusable Medical Devices
Medical devices have different contamination risks that affect cleaning and sterilization. Learn more about these different classes of reusable medical devices.…
Cleaning Agents Used in Medical Device Decontamination
Keeping a product clean and sterile starts with knowing what cleaning agents to use. Learn about some cleaning agents used in medical device decontamination.…
The Science Behind Sterility Testing for Medical Devices
Validation testing is the key to making sure products are safe for medical use. Learn about the science behind sterility testing for medical devices.
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Medical Device Packaging Testing Regulations
Packaging design and sterilization are just as crucial as product functionality. Learn a few facts about medical device packaging testing regulations.
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HIGHPOWER Letter to AAMI Regarding FDA Steam BI Requirements
April 20th, 2015 Association for the Advancement of Medical Instrumentation 4301 N Fairfax Drive Suite 301 Arlington, VA 22203-1633 USA RE: Current FDA Resistance Requirements…