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Q: I am in the quality assurance department at my company. We are a small start-up, and one of my jobs is to develop a quality risk management plan. Can...

Q: I am a quality control (QC) manager of a contract test laboratory. I am going to be upgrading the lab testing environment and would like to know if you...

Q: I work for a contract manufacturing organization (CMO) and our pharmaceutical manufacturing team has dedicated capital funds to update some of our manufacturing lines. I need to work with...

The application date of May 26, 2022 for the EU In Vitro Diagnostic Medical Devices Regulation (2017/746), commonly referred to as IVDR, has come and gone. IVDR has created challenges...