WHY YOU'RE HERE
Comprehensive Packaging Support for Medical Device Companies
We support medical device packaging from early development through validated production, helping teams reduce handoffs, address regulatory requirements, and prepare packaging systems for commercialization.
Our Capabilities:
Sterile Barrier Development
Pouch and tray packaging developed around device geometry, handling requirements, sterilization method, and regulatory needs.
ISO 11607 Validation
Packaging development and validation aligned with ISO 11607-1 and ISO 11607-2, including documented validation activities and submission support.
Pouch & Tray Sealing
Controlled sealing processes using Tyvek, medical paper, foils, laminates, and thermoformed tray systems.
IQ, OQ & PQ
Equipment and process qualification to establish repeatable seal parameters and demonstrate production-ready packaging performance.
Packaging Testing
Seal strength, dye penetration, burst testing, accelerated aging, distribution simulation, and post-sterilization evaluation.
Sterilization Coordination
Packaging developed with EO, gamma, and e-beam compatibility in mind, with sterilization activities coordinated as part of the broader program.
Pathway is built for the stage where you need manufacturing discipline without losing flexibility.
Built For Your Stage
Packaging Support Without the Volume Barrier
Development & Prototype Builds
Develop packaging concepts, materials, sealing parameters, and test strategies.
DV & Validation Builds
Produce controlled packaging builds for verification, validation, aging, distribution, and sterilization activities.
Early Commercial Production
Transition validated packaging processes into repeatable production without immediately requiring large-volume commitments.
You are not just buying packaging capacity. You are buying fewer problems between your device and the market.Â
Regulatory Ready Packaging
Packaging Is Part of the Device
Your sterile barrier system must maintain sterility, withstand distribution and storage, support sterilization, and generate the documentation required for regulatory submissions. Pathway supports packaging programs aligned with ISO 11607, FDA requirements, ISO 14971 risk management, and applicable ASTM and ISTA testing.
Ready To Move Forward
Let’s Review Your Packaging Needs
Whether you need a sterile barrier system developed from scratch or an existing packaging process moved into validation and production, our team can review your requirements and identify the right path forward.
Request a Packaging Review
Start the conversation.
Tell us what you need packaged. We will work through the details, together.