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Medical Devices

Medical Device Irritation Testing

Medical device irritation testing is a highly regulated industry (read more about medical device cleaning and validation) with requirements for cleaning, sterilization, reprocessing, and irritation testing. Similar to biocompatibility, irritation testing determines...

Medical Device Irritation Testing

Biocompatibility Testing for Medical Devices

Biocompatibility testing is commonly done for medical devices with testing ranging from screening of new materials to safety evaluations. The term "biocompatibility" refers to the compatibility of materials with living tissue. Biocompatibility testing is required...

Medical Device Biocompatiability Testing

Medical Device Testing | Cleaning & Validation

Medical device testing is of major importance to companies and manufacturers as a device failure can cost the company hundreds of thousands of dollars. Medical device testing helps to ensure kinks or vulnerabilities are worked out before the device reaches the...

Medical Device Reprocessing Testing

Looking for medical device testing? On March 12, 2015, the US Food and Drug Administration released a final guidance for medical device reprocessing entitled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”  This guidance was...

Medical Device Reprocessing Testing

Sterility Assurance Level (SAL)

Sterility assurance level, or SAL, is the chance that although something has been through the process of sterilization, there is still the potential the item is nonsterile as it is impossible to prove that every harmful organism has been destroyed. The sterility...

Sterility Assurance Level (SAL)

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