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. 

Medical device tray

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

    DOWNLOAD MEDICAL PKG COST STRUCTURE

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.

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.

Markets We Serve


Dordan’s custom thermoformed medical device trays are trusted across a range of healthcare sectors that require sterile, reliable, and compliant packaging solutions.

Medical Device Manufacturers (OEMs): We partner with global OEMs to design and produce rigid thermoformed trays for surgical tools, implants, and single-use devices. Our trays are engineered for clean sealing, sterile barrier integrity, and efficient handling throughout the supply chain.

Contract Manufacturers & Medical Assemblers: Dordan’s trays are optimized for manual and automated loading, offering press-fit, friction-fit, and snap-fit cavities to ensure secure staging of components. Designed for seamless integration into cleanroom assembly lines, our trays enhance throughput and precision.

Surgical Kit and Procedural Pack Providers: Our medical trays are ideal for organizing instruments within sterile surgical and procedural kits, improving clinical workflow and maintaining sterility from packaging through point-of-use.

Diagnostic and Pharmaceutical Companies: From custom trays for drug delivery systems to cleanroom-ready handling trays for diagnostic instruments, Dordan provides packaging that protects product integrity and meets regulatory demands.

DOWNLOAD DORDAN MEDICAL PROFILE

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

All cleanroom operations follow strict SOPs outlined in our certified QMS, supporting the manufacture of medical trays used in surgical kits, sterile packaging systems, and pharmaceutical assemblies.

Dordan's cleanroom

Quality Control & ISO-Certified Precision


Our ISO 13485:2016 and ISO 9001:2015 certified Quality Management System governs all aspects of production—from design validation to final inspection—ensuring defect-free, high-performance packaging that meets the regulatory and functional needs of the healthcare industry.

Our Quality Control Protocols Include:

  • First Article Inspections and Validations with detailed dimensional verification

  • Process Capability Studies (CPK) using automated optical inspection technology and full documentation available upon request

  • Lot Traceability and Change Control Procedures to support compliance

  • Cleanroom-Specific Protocols for gowning, material handling, and terminal cleaning

All inspections and measurement data are documented in real-time, providing transparency and consistency from prototype through production. We work closely with our clients’ engineering and quality teams to ensure all medical trays meet critical specifications and pass incoming inspection with ease.

Why Work with Dordan for Custom Medical Device Trays?


ISO 13485:2016 Certified for Medical Packaging

Medical tray packaging

ISO Class 8 Cleanroom Thermoforming

Precision-Engineered Tray Design

In-House Tooling & Prototyping for Rapid Development

Medical-Grade Materials & Sterilization Compatibility

Validation Support & Documentation

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

Request a Quote


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