Accelerate Product Development by 40% While Ensuring Complete Design Control Compliance
Transform complex development processes into a streamlined system that ensures products meet all regulatory requirements
The Design Controls Problem:
- ❌ Development teams struggle to maintain traceability across requirements
- ❌ Regulatory observations frequently cite inadequate design control procedures
- ❌ Technical documentation packages take months to compile
- ❌ Design changes trigger cascading documentation updates
The eLeaP Solution:
- ✅ 40% faster product development cycles
- ✅ Complete regulatory compliance (FDA, EU, ISO requirements)
- ✅ Automated technical documentation generation
- ✅ Real-time traceability with intelligent gap analysis
Stop risking recalls and regulatory actions due to inadequate design controls. The Design Controls module provides a comprehensive framework for managing product development from concept through commercialization. Unlike generic project management tools that miss regulatory nuances, eLeaP delivers purpose-built workflows that ensure compliance while accelerating development across medical devices, combination products, diagnostics, and regulated software. 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.
Transforming Product Development in Regulated Industries
Whether you’re developing medical devices, IVD products, combination products, or SaMD software, design controls are critical for regulatory approval and market success. Traditional approaches using disconnected spreadsheets and documents create gaps that lead to observations, delays, and field actions. eLeaP’s Design Controls System delivers comprehensive compliance without sacrificing development speed.
At the core of eLeaP Quality Management Software is its powerful Design Controls Module, a flexible system that adapts to your specific regulatory requirements and development processes. With integrated risk management, automated verification and validation protocols, and seamless technical file compilation, eLeaP ensures your products meet global regulatory requirements while reducing time to market.
Key Features
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Configurable Development Framework
Adapt the system to your development methodology—waterfall, agile, or hybrid. Configure phase gates, deliverables, and approval requirements based on product classification and regulatory pathway.
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Requirements Management System
Capture and control all requirements including user needs, regulatory standards, and technical specifications. Maintain bi-directional traceability with automatic impact analysis for changes.
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Dynamic Traceability Matrix
Automatically generate and maintain traceability from user needs through design outputs, testing, and validation. Instantly identify gaps, orphaned requirements, and incomplete verifications.
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Design Review Management
Configure stage-gate reviews with role-based participants, customizable checklists, and action tracking. Support both formal design reviews and agile sprint reviews with complete documentation.
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Verification & Validation Suite
Create, execute, and approve test protocols with electronic signatures. Link results directly to requirements and automatically flag deviations for investigation. Support all testing types from bench testing to clinical validation.
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Risk Management Integration
Seamlessly integrate risk analysis throughout development per ISO 14971, ICH Q9, or your specific framework. Track hazards, controls, and residual risk with automatic documentation updates.
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Technical Documentation Automation
Automatically compile Design History Files, Technical Files, or Design Dossiers based on your regulatory requirements. Generate submission-ready packages for FDA, EU, or other regulatory bodies.
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Development Transfer Protocols
Ensure successful scale-up and commercialization with transfer protocols, process validation requirements, and manufacturing readiness assessments.
Why Select eLeaP Quality?
With deep expertise across life sciences sectors, eLeaP understands that design controls aren’t one-size-fits-all. Our system adapts to your specific needs—whether you’re developing Class III medical devices requiring PMA, IVD products under IVDR, combination products with drug-device interfaces, or AI/ML-enabled software. The integrated QMS+LMS platform ensures teams are trained on procedures while executing controls, eliminating competency gaps.
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Navigate complex regulatory requirements with confidence
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Accelerate development timelines by 40% or more
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Eliminate design-related observations and findings
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Build submission-ready documentation automatically
Proven Benefits:
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Faster Regulatory Approvals
Submit 510(k)s, PMAs, CE marks, or other clearances with confidence using automatically generated documentation that meets regulatory expectations across all major markets.
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Reduced Development Costs
Eliminate redundant testing and documentation efforts through clear traceability and reusable templates, reducing development costs by 25-35% while maintaining compliance.
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Improved First-Pass Success
Identify issues early through structured reviews and comprehensive verification protocols, reducing costly late-stage changes and post-market corrections.
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Streamlined Regulatory Inspections
Impress FDA investigators, notified bodies, and other regulators with instant access to complete development history, clear traceability, and comprehensive risk documentation.
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Cross-Functional Collaboration
Enable R&D, quality, regulatory, clinical, and manufacturing teams to work together efficiently with role-based access and real-time project visibility.
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Scalable Architecture
Manage multiple products, projects, and development teams in one system. Support different development methodologies and regulatory pathways without system constraints.
The eLeaP Design Controls Module is trusted by life sciences companies worldwide for its ability to ensure compliance while accelerating development. Take the next step toward efficient, compliant product development. Start your free trial below or schedule a demo today.
The Design Controls Module is part of the comprehensive eLeaP Quality Management System.