Medical DevOps® is a comprehensive Enterprise Resource Planning and Product Lifecycle Management software designed specifically for medical device manufacturers and distributors. Our solution ensures FDA 21 CFR Part 820 compliance and implements ISO 13485 quality management requirements seamlessly.
21 CFR Part 820
Quality Management
Unique Device ID
Complete Traceability
FDA 21 CFR Part 820 Compliance: Our ERP-PLM software is specifically designed to meet FDA Quality System Regulation requirements for medical device manufacturers operating in the United States market.
Medical device regulation in all manufacturing and distribution processes ensures that medical devices reach healthcare professionals and patients with maximum safety and effectiveness guarantees. Our software implements processes according to FDA regulations and international standards, requiring continuous monitoring according to a quality manual that is often difficult to follow and needs practical day-to-day business solutions.
Complete traceability throughout the entire medical device lifecycle with automated batch and serial number tracking for FDA compliance.
Learn MoreIntegrated ISO 13485 quality management system built into every process, ensuring continuous compliance and audit readiness.
Learn MoreBuilt-in compliance tools for FDA 510(k), PMA, CE marking, and international standards including ISO 14971 risk management.
Learn MoreUnique Device Identification (UDI): Our system automatically generates and manages UDI labels according to FDA requirements, ensuring complete device traceability from component to patient.
The ability to trace every component and finished product (batch and serial number control) is vital in medical device manufacturing and distribution to ensure quality, efficient product recalls, and compliance with Unique Device Identification (UDI) requirements mandated by the FDA.
Advanced warehouse management for components and finished devices, maintaining complete traceability at every stage of the supply chain.
Request DemoAutomated identification processes for components, assemblies, and finished medical devices with full genealogy tracking.
Request DemoComprehensive post-market surveillance implementation including incident management, adverse event reporting, and MAUDE integration.
Request DemoSupply Chain Optimization: Competitiveness in the healthcare industry has shifted from product innovation to comprehensive control of manufacturing and supply chain operations.
Production management must focus on optimizing processes including product development, manufacturing, quality control, customer service, and logistics through integrated management of all these processes with algorithms that optimize key performance indicators at each phase.
Complete Design History File (DHF) management with automated design controls according to FDA 21 CFR 820.30 requirements.
Learn MoreIntegrated risk management system following ISO 14971 standards with automated risk analysis and mitigation tracking.
Learn MoreComprehensive CAPA management system ensuring FDA compliance with automated workflows and effectiveness verification.
Learn MoreOur ERP-PLM software delivers measurable results for medical device manufacturers and distributors across the USA
Medical DevOps® is a comprehensive ERP-PLM software for the medical device industry that
considers the fundamental processes of medical device manufacturing management, allowing the addition of
sector-specific procedures for comprehensive project management.
Our platform is specifically designed for USA medical device manufacturers and distributors, ensuring
complete FDA compliance while optimizing operational efficiency and reducing time-to-market.
If you need more information, send us the following form indicating your needs as a medical device
manufacturer or distributor operating in the USA market.
