Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS

Description

Medical device manufacturers face growing challenges in design controls, process validation, and regulatory compliance, often leading to inefficiencies, redundancies, and compliance risks. This two-day seminar introduces Lean Documentation and Lean Configuration principles to eliminate bottlenecks, enhance process efficiency, and improve compliance with FDA and ISO standards.

Led by Jose Mora, an industry expert in medical device quality systems, this seminar will provide practical strategies to streamline design control documentation, validation planning, risk management, CAPA, and supplier quality processes. By integrating lean principles with regulatory best practices, participants will gain a scalable, efficient, and audit-ready Quality Management System (QMS).

Whether you're struggling with complex validation documents, redundant traceability matrices, or inefficient supplier quality remediation, this seminar offers actionable solutions to simplify processes and improve compliance.

WHY YOU SHOULD ATTEND:

Is your medical device QMS filled with excessive documentation, redundant data, and compliance roadblocks? Many companies struggle with maintaining traceability, process…