Medical Device QMS Software for FDA-Regulated Industries
Medical Device Quality Management System Software Built for Real-World Complexity
The Medical Device Quality Management System Problem:
Many medical device manufacturers operate quality management systems across multiple disconnected platforms. Some rely on homegrown quality management approaches. Others maintain separate tools for design controls, document management, and training records. Some organizations still rely on paper-based systems, which hinder decision-making and increase compliance risks.
These fragmented approaches to medical device quality management systems don’t scale. They create information silos. They jeopardize your ability to demonstrate compliance during FDA inspections. And they delay the innovative, life-saving medical devices your patients need.
The result: longer development cycles, duplicated training administration, scattered audit documentation, and quality processes that can’t keep pace with ISO 13485, FDA 21 CFR Part 11, and MDSAP requirements.
The eLeaP Solution:
eLeaP offers a modern, cloud-based quality management software that replaces outdated medical device quality management systems, designed for FDA-regulated industries. Unlike single-purpose medical device QMS tools, eLeaP integrates your quality management system with your learning management system and performance management platform.
One unified medical device quality management system platform manages your design controls, documents, training records, quality audits, change control, risk assessments, and compliance, all seamlessly connected. Your training records feed directly into quality audits. Your compliance data informs performance metrics. Your audit trails are automatic.
Flexible workflows and templates scale your medical device QMS as your business grows. Every workflow, from design controls to supplier audits, maintains the consistency and traceability you need for FDA inspections and MDSAP certifications.
Key Differentiators:
- Integrated medical device QMS, learning management, and performance data
- FDA 21 CFR Part 11 and MDSAP compliance built in, not added on
- Real-time visibility into quality, training, and compliance metrics
- Automated audit trails and regulatory documentation
Develop high-quality medical devices quickly with an integrated medical device quality management system software that connects quality, training, and performance. Streamline your medical device QMS and unlock best-in-class quality, all in one unified platform.
Start your free 30-day trial. No credit card required. Get full feature access and implementation support. Or schedule a free session with one of our solution experts.
Unlock Transparency Across Your Entire Medical Device QMS
Gain end-to-end visibility across your complete medical device quality management system landscape, from design controls through design history files, quality audits, training records, and supplier management.
Find critical quality information in seconds from a single source of truth. Your quality team accesses real-time metrics on audit completion, training compliance, change control status, and supplier performance, all of which are integrated and interconnected. Your compliance officers have complete documentation trails ready for inspection. Your quality directors see leading indicators before issues emerge.
Key Visibility Capabilities:
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Intelligent QMS Dashboards
Real-time visibility into quality, training, and compliance metrics. Monitor medical device QMS health at a glance to ensure readiness for ISO 13485 and MDSAP requirements.
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Regulatory-Compliant Electronic Signatures
Single-source documentation with built-in FDA 21 CFR Part 11 compliance. Ensure data integrity and authenticity for all electronic records during FDA inspections and audits.
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Flexible Workflows and Templates
Scale your medical device QMS with flexible workflows that maintain consistency and traceability. Includes searchable repositories with complete version history and automatic audit trails.
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Automated Training and Audit Integration
Your training records feed directly into quality audits. Generate automated compliance reports and audit-ready documentation packages seamlessly across the unified platform.
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Design Control and Risk Visibility
Gain comprehensive visibility into design control status, risk assessments, and change impacts. Maintain the traceability needed for complex medical device innovation and regulatory filings.
Purpose-Built Medical Device Quality Management System Software for Regulatory Excellence
eLeaP medical device quality management system software is purpose-built for FDA-regulated industries. Your medical device QMS includes expert-validated compliance workflows, regulatory templates, and audit trail automation that anticipate FDA expectations.
Your design controls ensure first-time quality through integrated risk management. Your change control processes maintain complete traceability. Your training records demonstrate competency in every critical role, including supplier management documents, vendor qualification, and performance. Your corrective and preventive actions link directly to quality metrics and training needs.
Easily comply with ISO 13485, ISO 14971, FDA 21 CFR Part 11, FDA 820, MDSAP, and device-specific regulations. Your medical device quality management system grows as regulations evolve.
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Automatic audit trail creation for FDA 21 CFR Part 11 compliance
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Integrated design history file generation and traceability
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Supplier audits and corrective action tracking are tied to quality metrics
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Change impact analysis and automated notification workflows
Proven Benefits:
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Accelerated Product Developmen
Reduce design control cycles from months to weeks with automated document workflows and integrated design reviews. Streamline DHF compilation with real-time traceability between design inputs, outputs, verification, and validation. Accelerate 510(k) and PMA submissions with instant access to organized technical documentation.
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Reduced Compliance Risk
Ensure 21 CFR Part 820 and ISO 13485 compliance with validated electronic signatures, comprehensive audit trails, and automatic version control. Eliminate FDA 483 observations related to training gaps through automated training assignments triggered by document changes, NCRs, and CAPAs. Maintain continuous inspection readiness with integrated quality and training records.
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Lower Operational Costs
Cut quality management expenses by 60-70% compared to enterprise QMS solutions while eliminating separate LMS costs entirely. Reduce documentation overhead by 40% through automated workflows and integrated training management. Free quality teams to focus on continuous improvement rather than administrative tasks.
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Successful Regulatory Inspections
Present FDA inspectors and notified body auditors with complete, instantly accessible quality records including automated training verification for every SOP revision. Demonstrate robust CAPA effectiveness with integrated training completion metrics. Generate comprehensive reports showing document-to-training traceability in minutes, not days.
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Improved Collaboration
Connect quality, regulatory, clinical, and manufacturing teams through unified document control with role-based access and automated review cycles. Enable real-time collaboration on risk management files (FMEAs, hazard analyses) and design controls. Streamline supplier qualification with integrated document sharing and training verification.
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Flexible Scalability
Start with essential modules for early-stage medical device companies and expand as you grow through clinical trials to commercialization. Support everything from Class I device manufacturers with 10 employees to Class III companies with 500+ users. Add modules and users without data migration or system replacement as your quality needs evolve.
The eLeaP Quality Management System is purpose-built for medical device companies navigating FDA and ISO 13485 requirements. Our integrated QMS+LMS eliminates the gap between document control and training compliance that causes most 483 observations. Take the next step toward streamlined quality management. Start your free trial below or schedule a demo today.
The eLeaP Medical Devices QMS Software system is part of the comprehensive eLeaP Quality Management System.