Posts tagged with “Verification Testing”

Optics Expertise: Re-use IVD Verification Test Equipment in Manufacturing QC

Transfer to manufacturing is sometimes overlooked during the medical device product development program.  The FDA 21 CFR 820.30 requires manufacturers establish and maintain procedures to ensure that the device design is correctly translated into production specifications, and ISO13485 (required for Health Canada and Europe) requires transfer activities to be planned under section 7.3.1. You can […]