Medical Trays & Thermoformed Medical Packaging | ISO 13485:2016 Certified


Dordan Manufacturing is a fourth-generation, family-owned manufacturer of high-quality thermoformed medical packaging. From concept to production, we provide custom medical device trays, blisters, clamshells, kits, and handling trays engineered for safety, compliance, and performance. Certified to ISO 13485:2016 and ISO 9001:2015, Dordan offers full-service medical packaging solutions backed by in-house design, CNC tooling, plastics thermoforming, and ISO Class 8 cleanroom manufacturing.

Thermoformed medical packaging

 

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What Is Thermoformed Medical Packaging?


Thermoformed medical packaging is a manufacturing process where plastic sheets are heated until pliable and then formed over custom molds using vacuum or pressure to create precise, durable packaging solutions. This technique is widely used in the medical industry to produce trays, blisters, clamshells, and other packaging formats that securely house medical devices and components. Key benefits of thermoformed medical packaging Include:

  • Custom Fit and Protection: Each package is tailored to the specific dimensions of the medical device, ensuring a snug fit that minimizes movement and potential damage during transportation and storage.

  • Sterility Maintenance: Designed to accommodate sterilization processes, thermoformed packages help maintain the sterility of medical devices until the point of use.

  • Material Versatility: Utilizes medical-grade plastics such as PETG and HIPS, which are known for their clarity, strength, and compatibility with sterilization methods.

  • Cost-Effective for Medium & High Volumes: Once the tooling is created, thermoforming allows for rapid production of large quantities, making it a cost-effective solution for high-volume needs.

  • Design Flexibility: Capable of producing complex shapes and features, including compartments, flanges, and seals, to meet diverse medical packaging requirements.

At Dordan, our expertise in thermoforming, combined with our ISO Class 8 cleanroom manufacturing and ISO 13485:2016 certification, ensures that we deliver high-quality, compliant, and reliable medical packaging solutions tailored to your specific needs.

Medical Packaging Designed for Performance & Compliance


We specialize in custom thermoformed medical trays and packaging for a wide range of applications, including:

Rigid medical packaging
  • Medical Device Trays: Secure and sealable trays designed to hold and protect devices such as implants, surgical tools, and diagnostic equipment

  • Surgical and Procedural Kits: Organized trays for single-use and reusable instruments, configured to improve OR workflow and reduce setup time

  • Medical Blister Packaging: Thermoformed blisters sealed to foil or Tyvek® that offer tamper resistance and unit-dose protection

  • Medical Clamshells: Durable, hinged packaging used for syringes, tubing sets, and other device components

  • Component Handling & Assembly Trays: Designed for cleanroom assembly, automation, and shipping of medical components

 

Fully Integrated Medical Thermoforming Capabilities


We provide end-to-end medical packaging solutions, including:

This integrated approach improves speed, traceability, and consistency throughout the medical packaging development process.

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Markets We Serve in Medical Packaging


Dordan partners with medical device OEMs, contract manufacturers, and healthcare suppliers to deliver custom thermoformed packaging solutions engineered for sterility, safety, and compliance. Our expertise supports a wide range of medical and pharmaceutical applications, including:

Medical Device Manufacturers: We design and manufacture medical trays, blisters, and clamshells that protect and maintain the sterility of single-use and reusable medical devices—from orthopedic implants to surgical instruments and diagnostic tools.

Surgical and Procedural Kit Providers: Our thermoformed trays for surgical and procedural kits are custom-configured for organized instrument layout, intuitive use, and efficient sterilization. Ideal for both sterile and non-sterile packaging formats.

Contract Manufacturers and Assemblers: Dordan supplies handling and assembly trays used in manufacturing, staging, and cleanroom assembly of medical components and kits. Our trays are automation-ready and designed for durability and precision.

Pharmaceutical and Diagnostic Applications: We manufacture rigid plastic blisters and trays used for packaging pharmaceuticals, diagnostic kits, and other regulated healthcare products—ensuring proper containment, labeling, and compliance throughout the supply chain.

ISO Class 8 Cleanroom Medical Packaging


Dordan’s ISO Class 8 certified cleanroom is purpose-built for the manufacture of medical packaging with tight form and cut tolerances and contamination control.

Dordan's cleanroom

The cleanroom features:

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

  • Terminal cleaning protocols and FDA-certified material handling processes

  • Particulate and bioburden monitoring in compliance with ISO 14644

  • Automated optical inspection for CPK data and real-time quality analysis

  • GMP-based gowning, material handling, and terminal cleaning protocols

All cleanroom production is supported by:

  • First Article Validation (FAV) and full dimensional reports

  • Process capability studies (CPK) with optical inspection technology

  • Lot traceability, material certification, and change control documentation

All cleanroom operations are governed by our ISO Class 8 certified quality management system, which ensures the production of consistently clean, on-spec packaging for critical healthcare applications

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Quality Assurance in Medical Packaging


At Dordan, quality control isn’t just a standard—it’s a systemized, validated process built into every custom medical packaging solution we produce. From ISO-certified production protocols to material traceability and cleanroom manufacturing, we ensure that every medical tray, blister, or kit meets the most stringent regulatory, performance, and cleanliness requirements.

ISO-Certified Medical Packaging Manufacturing

  • ISO 13485:2016 Certified – for the design and manufacture of medical-grade thermoformed packaging. This certification reflects our ability to meet global regulatory requirements for medical devices and ensures a risk-based approach to quality control.

  • ISO 9001:2015 Certified – for total quality management across all operations, emphasizing process consistency, documentation, and continuous improvement.

Process Validation & Quality Control

  • First Article Inspection (FAI) to verify dimensional accuracy and design intent prior to production.

  • Process Validations (IQ, OQ, PQ) to establish and document consistent performance and repeatability in medical packaging manufacturing.

  • Statistical Process Control (SPC) and CPK analysis to monitor and maintain critical dimensions during forming and trimming operations.

  • Post-production Sampling using Acceptable Quality Level (AQL) standards to verify lot conformity and compliance.

  • Automated Optical Inspection to non-destructively validate high-tolerance features and geometries.

Traceability & Regulatory Support

We maintain complete lot-level traceability, linking material certifications, tooling data, inspection records, and production runs. All materials used in medical packaging production are sourced from FDA-compliant suppliers and selected to align with your sterilization and end-use requirements, including gamma, EtO, and e-beam compatibility.

From prototype to production, Dordan’s ISO-certified quality systems and manufacturing capabilities ensure that your medical packaging meets the highest standards of safety, compliance, and performance—every time.

Why Leading Medical Companies Choose Dordan


  • Over 62 years of thermoforming experience

    Medical procedural tray
  • Certified to ISO 9001:2015 and ISO 13485:2016 

  • Custom-designed medical trays, blisters, kits, and WIP trays made in the USA

  • In-house design, tooling, and cleanroom production

  • Ideal for short runs, high volumes, and everything in between

  • 4th generation family-owned and operated

Explore Related Pages


Medical Device Trays

Medical Kits

Medical Blisters

Medical Clamshells

Medical Handling Trays

Request a Free Medical Packaging Consultation


Need help developing your next thermoformed medical tray or surgical kit package? Contact Us today to schedule a free consultation with our engineering team, or Request a Quote for your next project.