This year has been somewhat up and down for medical device developers. The medical device excise tax was approved, and any devices sold starting in 2013 will be subject to […]

As part of their effort to provide clearer directions for industry, the FDA recently published a new guidance document for ICH Q8, Q9, and Q10.This document is taken […]

Visit http://pacificbiolabs.com/learning-center/medical-device/reusable-device-validations/webinar/ to download a recorded version of the webinar or to view the slides from the presentation. This webinar presented an overview of FDA regulations regarding reusable medical device cleaning, disinfection, and […]

PBL Adds MTT Cytotoxicity Assay Pacific BioLabs has validated a quantitative assay for cytotoxicity - the MTT - and is now offering it to all PBL clients. Please inquire about the […]