Engineering
EagleMed Eagle Medical Inc.

Engineering Services

Technical Expertise That Moves Products Forward

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At Eagle Medical, engineering support means more than just packaging design, it’s about making sure your product is sterile, validated, and ready to meet regulatory expectations. Our experienced team helps you design and optimize packaging systems that align with your device, sterilization modality, and intended use, all while accelerating your timeline to submission and approval.

Whether you're launching a new product or remediating an existing one, we serve as a strategic extension of your team, providing hands-on engineering guidance backed by deep experience in FDA, ISO, and EU regulatory frameworks.

Our Core Capabilities

Package Engineering & Optimization

  • Custom sterile barrier system design
  • Backer card and tray development for secure, ergonomic presentation
  • Pouch and multilayer film configuration
  • Design for sterilization compatibility (EtO, VH₂O₂, gamma)
  • Aseptic presentation and user experience considerations

Process Validation & Protocol Development

  • Heat-seal and packaging process validation
  • Sterilization cycle development (EtO, VH₂O₂)
  • True Validation™ documentation for regulatory submissions
  • Accelerated aging and shelf-life simulation support
  • Documentation for ISO 11607, ISO 13485, and FDA 21 CFR Part 820

Regulatory Support & Documentation

  • Validation report generation
  • Packaging validation protocols and data sets
  • Technical file inputs for CE marking
  • Change control documentation and revalidation support
  • Guidance aligned with FDA, ISO, and EU MDR standards

Strategic Support for Medical Device Teams

  • Collaboration with client engineers and regulatory leads
  • Cleanroom-integrated solutions for smoother scale-up
  • Trusted by Class II & III OEMs for device packaging and launch
  • Rapid-cycle iteration during R&D and submission prep
  • Clear documentation that passes audits and meets global expectations

Your product deserves packaging and validation that’s as precise as the device itself. Partner with Eagle’s Engineering Services team to reduce development risk, compress timelines, and build a compliant path to market, from cleanroom to clinical use.