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Medical Device Packaging

Secure, compliant medical packaging built around your device and your schedule.

Janco provides custom medical packaging, design support, and cleanroom manufacturing that help you get to market quickly without sacrificing quality. Our U.S.-based team guides material selection, labeling, prototyping, and FDA-focused decisions from the first discussion through production.

Why teams choose Janco for custom medical device packaging

  • 60+ years in medical manufacturing with a focus on foam fabrication and plastic thermoforming for packaging and devices.
  • U.S.-based, Class 7 and Class 8 ISO certified cleanrooms for packaging and assembly. Facilities are FDA registered and ISO 13485 certified.
  • Design assistance and regulatory guidance, including materials, sourcing, labeling, and prototyping that align with medical industry requirements.
  • Speed to market supported by in-house capabilities, an engineering-led process, and supply chain reliability.

We build custom medical packaging solutions across a wide range of formats to fit your device and the needed sterilization method. Our facilities have the capabilities to manufacture:

We work with medical-grade, biocompatible materials selected to handle your validation plan and sterilization needs, including EO, Gamma, E-Beam, Peroxide, Dry Heat, and Autoclave.

Our medical device packaging materials include:

Plastics
  • TPU
  • PET
  • PETG
  • PETE
  • HIPS
  • Acrylic
  • PVC
  • Kydex
  • ABS
  • PC
  • PP
  • PS
  • HDPE
Foams
  • Closed-cell polyethylene foam
  • Cross-linked foam
  • TPO foam

Custom medical packaging design

Every custom medical device packaging project is engineered to fit your unique device needs, with the goal to add value at every step of the process.

Our design team collaborates on layout, protection, usability, and tray organization to streamline procedures and reduce handling. You decide how hands-on you want to be throughout the design phase of the process; if you already have specs or specific guidelines, we can consult on materials and best practices or execute your plans.

Medical device packaging

We package and seal in ISO Class 7 and 8 cleanrooms, including sealing Tyvek pouches from trusted vendors and producing TPU sleeves when needed, with the flexibility for small and large production runs.

Quality, Compliance, and Validation

Compliance is an essential element of any medical manufacturing project. When you work with Janco for medical packaging projects, you can have full confidence knowing that we boast:

  • An FDA-registered facility and ISO 13485-certified quality management system
  • ISO 14644-1 Class 7 and Class 8 certified cleanrooms monitored and tested regularly
  • Validation testing to ASTM, ISO, or customer standards
  • Full traceability from product ID to raw material lots
  • Processes audited internally, by independent bodies, and by customers and FDA.

Markets and use cases

Our team has decades of experience working across a wide range of medical specialties, including: 

  • Orthopedics
  • Vascular
  • Respiratory
  • Endoscopy
  • Laboratory
  • Cardiology
  • Spinal
  • Dental
  • Pharmaceutical
  • Veterinary
  • Drug delivery
  • And more

Our Medical Device Packaging Process

Over six decades, our team has perfected and streamlined our process, so you can always rely on knowing what to expect from a medical device packaging project with Janco.

Put simply, our process includes:

  1. Requirements and risk review
  2. Concept and prototyping
  3. Material selection and packaging design
  4. Pilot and qualification
  5. Cleanroom packaging and sealing
  6. Support for sterilization and labeling
  7. Ongoing improvements through audits and feedback
sterile medical packaging

Frequently Asked Questions

How does Janco support regulatory compliance in packaging?

Our facilities and processes align with FDA and ISO 13485 requirements. We provide documentation, traceability, and quality controls to help streamline audits and submissions.

What is contract packaging versus contract manufacturing?

Contract packaging focuses on the packaging, sealing, and labeling of devices, while contract manufacturing covers the full build of the device. Janco can support both or just the packaging stage, depending on your needs.

Which medical packaging materials do you use?

Common plastics include PET, PETG, ABS, PC, PP, PS, HDPE, and TPU. Common foams include closed-cell polyethylene and TPO. Selection depends on protection needs and sterilization.

Can you support sterile barrier systems and pouch sealing?

Yes. We seal Tyvek pouches from trusted vendors in Class 7 cleanrooms and can incorporate TPU sleeves when appropriate.

Are your facilities FDA registered and ISO certified?

Yes. FDA registered, ISO 13485 certified, with ISO 14644-1 Class 7 and 8 cleanrooms.

Do you help with packaging design and prototyping?

Yes. We offer hands-on medical packaging design assistance, prototyping, and materials guidance to move from concept to cleanroom efficiently.

Need a team that can handle all of your medical device packaging needs with innovative processes and the most reliable technology? We’re happy to help.

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