Comprehensive Technical Solutions for Medical Device Development
Eagle Medical's Engineering Services division serves as a strategic technical partner for medical device manufacturers, providing specialized expertise across the complete product development lifecycle. Our multidisciplinary engineering team combines deep regulatory knowledge with practical manufacturing experience to deliver solutions that accelerate time-to-market while ensuring compliance and cost-effectiveness.
Core Engineering Capabilities
Primary Package Design
Sterile barrier system engineering optimized for specific device requirements
Material selection and compatibility analysis for various sterilization modalities
Package configuration optimization for aseptic presentation and user experience
Structural integrity analysis and finite element modeling for complex geometries
Shelf-life optimization through advanced barrier property modeling
Backer-Card Design & Optimization
Thermoformed tray design with integrated sealing and presentation features
Material thickness optimization for cost reduction and performance enhancement
Cavity design for secure device retention and damage prevention
Ergonomic considerations for healthcare provider usability
Automated packaging line compatibility assessments
Validation & TestingProject ManagementRegulatory SupportDesign for ManufacturingFAQ
Random Sample Testing Programs
Statistical sampling protocols per ANSI/AAMI/ISO standards
Package integrity testing using ASTM F2338 and alternative methods
Accelerated aging studies with real-time correlation validation
Environmental stress testing including temperature, humidity, and vibration
Microbial challenge testing and sterile barrier effectiveness validation
Process Validations
Comprehensive validation protocols for packaging and sterilization processes
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Heat-seal validation with ongoing monitoring and control strategies
Sterilization cycle development and validation support
Change control and revalidation management
Integrated Project Leadership
Cross-functional team coordination across regulatory, quality, and manufacturing disciplines
Timeline development and milestone management with risk mitigation strategies
Vendor qualification and supply chain optimization
Budget management and cost control throughout project lifecycle
Stakeholder communication and executive reporting protocols
Quality System Integration
Design control implementation per FDA 21 CFR Part 820
Risk management (ISO 14971) integration and documentation
Configuration management and design change control
Verification and validation planning and execution
FDA Submission Consulting
510(k) submission preparation and regulatory strategy development
Predicate device analysis and substantial equivalence documentation
Clinical evaluation support and biocompatibility assessment coordination
FDA correspondence management and response preparation
Post-market surveillance and adverse event reporting consultation
International Regulatory Support
European MDR compliance and CE marking preparation
Health Canada and other international regulatory pathway guidance
ISO 13485:2016 implementation and maintenance support
Global harmonization strategy development
Manufacturing Optimization
Cost-effective design solutions balancing performance and manufacturability
Material consolidation and standardization strategies
Process capability analysis and manufacturing feasibility assessments
Automation compatibility and scalability planning
Supplier capability evaluation and qualification support
Continuous Improvement Integration
Lean manufacturing principle application
Six Sigma methodology implementation for process optimization
Value engineering and cost reduction initiatives
Technology transfer and manufacturing scale-up support
Specialized Technical Services
Advanced Problem Solving
Root cause analysis for packaging and product failures
Corrective and Preventive Action (CAPA) development
Technical due diligence for M&A
Competitive analysis and benchmarking
Innovation & Technology Development
Emerging technology evaluation and implementation
Intellectual property landscape analysis
Patent application support and prior art searches
Technology roadmap development
Frequently Asked Questions
Our Engineering Services team functions as an extension of your internal capabilities, providing specialized expertise when and where it's needed most. We integrate seamlessly with your existing teams through collaborative project management, knowledge transfer protocols, and flexible engagement models that can range from short-term consulting to full project leadership.
We follow comprehensive industry standards including ANSI/AAMI/ISO protocols for statistical sampling, ASTM F2338 for package integrity testing, FDA 21 CFR Part 820 for design controls, ISO 14971 for risk management, and ISO 13485:2016 for quality management systems. Our validation protocols are designed to meet both FDA and international regulatory requirements.
Yes, we provide comprehensive regulatory support for both FDA submissions and international pathways. This includes 510(k) preparation, European MDR compliance and CE marking, Health Canada submissions, and other international regulatory requirements. Our team develops global harmonization strategies to streamline multi-market approvals and reduce regulatory burden.
Our DfM approach balances performance requirements with manufacturability and cost-effectiveness. We conduct process capability analysis, material consolidation strategies, automation compatibility assessments, and scalability planning. Our methodology incorporates Lean and Six Sigma principles to optimize manufacturing processes while maintaining product quality and regulatory compliance.
We provide integrated project leadership with cross-functional team coordination across regulatory, quality, and manufacturing disciplines. Our project management includes timeline development with risk mitigation strategies, milestone tracking, budget management, vendor coordination, and regular stakeholder communication through executive reporting protocols.
Our specialized services include root cause analysis for product failures, CAPA development and implementation, technical due diligence for mergers and acquisitions, competitive analysis and benchmarking, emerging technology evaluation, intellectual property landscape analysis, patent application support, and strategic technology roadmap development.
Strategic Partnership Approach
Engage Eagle Medical's Engineering Services team to leverage our comprehensive technical expertise and accelerate your medical device development objectives. Our collaborative approach ensures knowledge transfer while delivering measurable results that enhance product quality, reduce development costs, and accelerate market entry.
