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Medical Device, News | April 8, 2016
NEW ISO 13485:2016 GUIDANCE PUBLISHED
On March 1, 2016 the International Organization for Standardization published the new edition of the ISO 13485 standard. Previously updated in 2003, the revision places more emphasis on the quality […]
Analytical Chemistry, Medical Device
Detailed Methods for Performing Extractables Testing of Materials
A recent article from the Parenteral Drug Association (PDA) Journal provides some of the best information we have found on methods to determine and characterize extractables. It is definitely suggested […]
Medical Device
FDA Expectations for Reusable Device Reprocessing Validations
In March of 2015, the FDA published a new guidance document titled, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. A draft guidance on the same subject […]
Medical Device, Microbiology
Why Understanding Bioburden and Sterilziation is Key to Medical Device Development
Pacific BioLabs and Nutek used to work closely together to perform the microbiology and sterilization needed for medical device sterilization validation programs. Nutek was bought out by BART and the […]