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.
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
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
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
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