Grantek’s has decades of experience working in the Life Sciences industry. Grantek has also helped medical device manufacturers improve their operations. Medical device manufacturers require robust system integration to ensure quality, safety, and regulatory compliance while maintaining operational efficiency.
Email info@grantek.com to learn how your operations can benefit from Grantek’s experience.
A well-integrated medical device manufacturing environment connects several critical systems:
- Quality Management System (QMS) – Central to regulatory compliance and product quality.
- Enterprise Resource Planning (ERP) – Manages resources, production scheduling, and supply chain.
- Manufacturing Execution System (MES) – Controls production processes and provides real-time monitoring.
- Product Lifecycle Management (PLM) – Manages product data from concept through end-of-life.
- Electronic Device History Records (eDHR) – Maintains complete manufacturing records for traceability.
Key Integration Benefits:
- Regulatory Compliance – Automated documentation and traceability for FDA, ISO 13485, and MDR requirements.
- Quality Assurance – Closed-loop quality processes with automated checks and balances.
- Production Efficiency – Streamlined workflows with reduced manual data entry and errors.
- Supply Chain Visibility – End-to-end tracking from components to finished devices.
- Data-Driven Decisions – Unified analytics across manufacturing, quality, and business processes.