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Medical device trays

Custom thermoformed medical tray packaging engineered to protect medical devices, support sterility, and maintain device integrity through point of use

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medical device tray
thermoformed medical tray

Medical device tray packaging

A thermoformed medical device tray is a rigid packaging format formed around the shape and dimensions of a medical device to provide protection, organization, and controlled presentation through handling, distribution, storage, and point of use.

For sterile barrier packaging applications, raised seal flanges can be designed for compatible medical lidding. PETG gauge and package design are developed with the specified sterilization method and application requirements in consideration.

Dordan designs and manufactures medical device trays around the protection, handling, and presentation requirements of the device. Tray geometry and dimensional requirements are engineered for consistent thermoforming, device fit, and package performance.

Medical device trays can support:

  • FDA Class I, II, and III medical devices
  • Complex device geometries and critical features
  • Sterile and non-sterile packaging applications
  • Device access and aseptic presentation requirements

Medical tray design features

Engineered for medical device packaging performance

Medical tray design must balance device requirements with the thermoforming process to achieve consistent product protection, package performance, and manufacturability.

Thermoformed medical tray packaging

Protection & Device Integrity

Medical trays provide structural protection to help maintain device efficacy during handling, distribution, sterilization, storage, and point of use. Tray geometry protects critical device features and reduces the risk of damage.

Medical syringe tray

Device Retention & Orientation

Custom-formed cavities hold, restrain, and orient medical devices within the tray. Retention features limit movement while maintaining device position for protection, presentation, and removal.

Medical device tray

Material Distribution & Sealing

Controlled material distribution helps prevent thin areas and puncture risk. Consistent seal-flange geometry supports reliable sealing with compatible lid stock such as Tyvek® when a sterile barrier is required.

Medical tray design, tooling, & manufacturing

From medical device tray package design through production

Custom thermoformed medical trays are developed and manufactured in-house from initial package design and prototype tooling through production and cleanroom thermoforming. Integrated engineering, tooling, and quality systems support consistency throughout medical device tray packaging programs.

medical tray engineering drawing

Medical Tray Design & Engineering

Medical trays are designed in Siemens NX around device geometry, packaging requirements, and the thermoforming process. Engineering drawings and project-specific engineering reports document critical dimensions, design requirements, material distribution, and manufacturability before tooling is built.

CNC for producing medical packaging thermoform tooling

Medical Tray Thermoform Tooling

Prototype and production tooling is CNC-machined in-house from aluminum using NX CAM. Prototype tools support sample development and customer review before production tooling is finalized. Production tools are engineered for dimensional control, cavity consistency, material distribution, seal-flange requirements, and repeatable thermoforming performance.

Medical packaging manufacturing company

Cleanroom Medical Tray Thermoforming

Medical device trays are thermoformed on dedicated equipment within Dordan’s ISO Class 8 cleanroom under an ISO 13485:2016-certified quality management system. Controlled forming parameters support consistent material distribution, cavity definition, dimensional repeatability, and seal-flange geometry across production runs.

cleanroom-thermoforming-medical-packaging-2

Cleanroom thermoforming for medical device trays

Medical device trays are thermoformed in Dordan’s 3,200 sq. ft. hard-wall ISO Class 8 cleanroom under an ISO 13485:2016-certified quality management system. Temperature, humidity, and airborne particulate levels are controlled and monitored, with production governed by documented standard operating procedures and quality controls.

Quality requirements are established for each medical device tray program and include first article inspection and first article validation of critical dimensions and package requirements. Project-specific dimensions and tighter tolerances beyond Dordan's standard thermoforming tolerances can also be incorporated when required. Process validation and Cpk capability studies are available upon request.

For sterile barrier trays, dimensional control, consistent material distribution, and seal-flange performance are critical to maintaining package integrity and supporting consistent lid sealing.

Cleanroom and quality capabilities include:

  • 3,200 sq. ft. hard-wall ISO Class 8 cleanroom
  • ISO 13485:2016-certified quality management system
  • Controlled and monitored temperature, humidity, and airborne particulate
  • First article inspection and validation
  • Project-specific dimensions and tighter tolerance requirements
  • Process validation and Cpk capability studies upon request

Start your medical tray packaging project

Bring your device and packaging requirements to Dordan for a custom thermoformed tray engineered for protection, performance, and consistent production

Request a Quote Call (815) 334-0087