White Paper: Medical

Product Centric QMS: A Critical Advantage for Regulated Companies


Medical device manufacturers must establish quality systems to comply with FDA regulations and industry standards like ISO 13485. This whitepaper explains why product centric QMS solutions are critical to simplify compliance.

Traditional quality management system (QMS) solutions were developed to help comply with regulations with a primary focus on automating paper-based processes. However, today’s complex product medical device manufacturers need systems to manage documents, SOPs, training records, and CAPA/quality processes in addition to the complex product record.

A product centric QMS solution provides a single, unified solution that links quality and training information to the entire product record. Read this whitepaper to learn how this approach simplifies compliance to FDA regulations.

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