SOP Product Registration and Certification
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Use this SOP Product Registration and Certification template to systematically guide your team through the medical device registration, certification, and UDI creation process for both EU and US markets. This document ensures compliance with all technical documentation, conformity assessment, and declaration of conformity requirements, and should be completed whenever a new or updated medical device is being prepared for market release. It is essential for maintaining regulatory compliance and market access, and must be filled out prior to product launch to document all required steps and responsibilities.