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Critical Packaging

Precision Engineering for a Better World

Medical Device Packaging

For more than four decades, we have worked with medical and biotech companies. During this time, we have become very well acquainted with stringent FDA and customer requirements. We have developed a proven track record of producing top quality, particulate-free thermoformed trays on time and in budget. And, we have perfected our superior trim technology to consistently produce particle free edges.


This is one of the ways that we have established our reputation for delivering the highest quality custom medical device packaging in the business. Using a wide array of FDA approved materials, Merrill’s packaging can withstand any number of sterilization methods, such as ETO, gamma, e-beam, dry heat or steam.



Put simply, thermoforming receives a roll of plastic, heats it, and molds it into a perfectly formed package (many, many times over). Straightforward as it sounds, it is a complex process that must carefully consider heat transfer, pressure vacuum, and the dynamics of forming. We use precision microprocessor-controlled machinery to ensure we can produce huge quantities of flawless packages according to your validated design recipe.


Custom Design

After your thorough Q&A session with us, our engineering team takes your objectives, specs, and ideas and then factors in contingencies like unit cost, long-term quality, and material handling requirements to come up with an initial package design. From that point forward, you will be consulted at every stage in an effort to boost quality, shorten turn around times, and minimize costs. Eventually, we’ll present an approved CAD design and 3D printed model that we can use to get an idea of size and style.


In-house Tooling

The design is only as good as the tooling. Any tiny flaw in the tooling means that mistake will be replicated over and over. We’ve developed a system of checks to ensure your tooling is flawless. With your approved CAD design, we can manipulate the geometry and export it to our Computer-Aided Manufacturing software (CAM) which allows us to write the mold program that can cut virtually any shape with both two and three dimensional surfaces in a matter of hours.



ISO 14644-1

The ISO 14644-1 standard sets the global gold standard for cleanroom air cleanliness. It defines nine classes based on precise particle concentration limits, ensuring consistent evaluation through standardized testing methods. From pharmaceuticals to microelectronics, industries rely on this framework to guarantee product quality, process integrity, and worker safety in sensitive environments.

ISO 13485:2016

Within the rigorously regulated world of medical devices, ISO 13485:2016 reigns supreme as the international benchmark for quality management systems (QMS). This comprehensive standard orchestrates a flawless symphony of processes, guiding manufacturers from initial design through post-market vigilance. Every intricate note – qualified personnel, risk management, meticulous product realization, and unwavering surveillance – contributes to the harmonious crescendo of safe, reliable devices. Compliance with ISO 13485 transcends mere paperwork; it's a resolute commitment to patient well-being, earning global trust and unlocking market access. For manufacturers, it's the symphony conductor, ensuring every device delivers a flawless performance.


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Since 2010 we have saved:

21,035,664 pounds of solid waste, diverted and recycled.

20,617,631 pounds in greenhouse gas emissions, reducing solid waste means less emissions.

13,227,625 MWH (Megawatt Hours), less emissions means less energy expended.

Like most every business, we use our planet’s natural resources in the course of our daily operations. However, at Merrill’s we are committed to operating in a way that protects, preserves and sustains this beautiful planet we all share. We truly believe that we have a responsibility to be a wise consumer of our natural resources and, as a symbol of that commitment, are proudly certified as an official California Green Business.

We are ready now

To support your thermoform project with speed, services, and solutions