Medical Devices ISO 13485:2016

In March 2024, Omnex partnered with a leading contract manufacturer in the medical device industry to help them achieve ISO 13485:2016 certification. Specializing in thermoformed enclosures for MRI and other medical equipment, the client faced significant challenges with their existing Quality Management System (QMS), which was not aligned with ISO 13485 requirements. Through a comprehensive Gap Analysis, Omnex identified critical deficiencies and developed a strategic plan to revamp their QMS, focusing on key areas like process documentation, team training, and performance metrics.

Over the course of several months, Omnex guided the organization through the development and implementation of a robust, ISO 13485-compliant QMS. This included creating and documenting all management and manufacturing processes, conducting staff training, and ensuring preparedness for certification audits. The client successfully passed their Stage 1 audit, with full certification expected by September 2024.

Download the full case study to learn how Omnex can help your organization achieve ISO 13485 certification.