Medical Device Trays | Thermoformed Medical Trays | ISO 13485:2016 Certified


Dordan Manufacturing specializes in custom thermoformed medical device trays engineered for sterility, performance, and ease of use. Available for production in our ISO Class 8 cleanroom or standard thermoforming facility, our rigid plastic trays provide sterile barrier protection, intuitive access for healthcare practitioners, and compliance with industry regulations. We are ISO 13485:2016 and ISO 9001:2015 certified, offering end-to-end solutions with in-house design, tooling, thermoforming, and cleanroom manufacturing. 

Janet booth HBL tray compressed

What Are Thermoformed Medical Device Trays?


Thermoformed medical trays are rigid plastic packages sealed with Tyvek® or other lidstock materials to create a sterile barrier system.

Ideal for packaging surgical tools, implants, and single-use medical devices, these trays are:

  • Easy to load, seal, and sterilize

  • Resistant to punctures and contamination

  • Designed for intuitive peel-open access and safe device removal

  • Preferred by healthcare professionals for their durability and simplicity

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Medical Device Tray Features & Benefits


As a custom thermoformed tray manufacturer since 1962, Dordan designs medical trays with features that improve function, safety, and production efficiency:

Medical device tray
  • Raised seal flange for Tyvek® or lidstock application and clean, secure seals

  • Snap-fit, friction-fit, and press-fit cavities to hold devices in place

  • Finger access and peel tabs for intuitive and safe device removal

  • Pragmatic tag and die design for clean cut edges and minimal flash

  • Medical grade material PETG material for strong form and consistent sealing

For customers who prefer pouch packaging, trays can also be placed in Tyvek® pouches as an alternative sterile barrier system.

Full-Service Medical Tray Design & Manufacturing


Dordan offers fully integrated medical tray development, including:

Our team of packaging engineers designs both the tray geometry and the tooling used to manufacture it, eliminating translation errors and enabling rapid prototyping and production.

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Cleanroom Thermoforming for Medical Device Trays


Dordan’s ISO Class 8 certified cleanroom is purpose-built for the thermoforming of medical device trays that require tight tolerances, clean seals, and contamination control. Designed to meet the rigorous standards of ISO 14644, our cleanroom manufacturing environment ensures that each tray maintains sterility, structural integrity, and compliance throughout its lifecycle.

Key Cleanroom Features Include:

  • Keifel Speedformers with automated forming, die cutting, stripping, and stacking

  • Cascading filtered airflow design to manage particulate and bioburden levels

  • Terminal cleaning protocols and material wipe-down for all incoming goods

  • GMP-compliant gowning rooms and material staging zones for controlled entry

  • Particulate count testing and environmental monitoring performed regularly

 

Why Work with Dordan for Custom Medical Device Trays?


What sets us apart:

Medical blisters

ISO 13485:2016 Certified 

ISO Class 8 Cleanroom Thermoforming

Risk-Based Engineering 

In-House Tooling & Prototyping for Rapid Development

4th Generation Family-Owned Since 1962, Made in USA

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Looking for a reliable partner for custom thermoformed medical trays? Contact Us today or Request a Quote to get started on your project.