SYSPRO empowers medical device manufacturers with tools to manage complex compliance requirements, maintain rigorous quality standards, and achieve end-to-end traceability.
Whether producing surgical instruments, diagnostic equipment, or implantable devices, SYSPRO supports you with integrated controls for materials, documentation, and production processes—streamlining operations while reducing risk.
Medical device manufacturing requires tight control over design revisions, lot tracking, and process validation. SYSPRO centralizes data and documentation across your supply chain, enabling compliance with FDA, ISO 13485, and MDR standards.
With robust audit trails, recall readiness, and automated workflows, SYSPRO helps you deliver safe, reliable products on schedule.
Maintain detailed records of manufacturing activities for every product, supporting audits and regulatory submissions.
Track components and finished devices across batches and suppliers with full forward and backward traceability.
Align with FDA 21 CFR Part 11, ISO, and EU MDR requirements through digital documentation and secure approvals.
Manage revisions to product designs and processes with built-in approval workflows and version tracking.
Monitor inspections, manage non-conformances, and initiate corrective actions from one integrated system.
Generate real-time reports, trace product lineage, and retrieve supporting documentation instantly for internal or external audits.
Configure SYSPRO to match your unique manufacturing processes, regulatory requirements, and operational workflows. Our industry-agnostic approach ensures optimal system performance regardless of your production environment or business model.
With built-in regulatory support, traceability, and quality controls, SYSPRO enables medical device manufacturers to meet compliance standards, minimize risk, and deliver life-critical products with confidence.
Try SYSPRO for your business
