How to Navigate Medical Device Shipping Requirements

Custom Case Manufacturing Medical & Pharmaceutical Shipping

medical device shipping requirements

Medical device shipping requirements are stringent. Per the International Organization for Standardization (ISO), the main pillars include tests to ensure medical devices:

✓ Remain sterile until their point of use

✓ Maintain integrity throughout their lifetime

✓ Can withstand handling, distribution and storage hazards

All the while, packages must use raw materials that are safe and create a microbial barrier — and also are equipped with the proper labeling for identification purposes.

With a lot of boxes to check for sound shipping, medical device manufacturers can lean on a custom case provider like Cases By Source for assistance to meet necessary requirements.

We’ll Work with You to Ensure…


Proper Temperature Control

As the FDA notes, many medical devices can fail to perform properly if they are exposed to high levels of heat or humidity. Based on the nature of the device, these conditions can compromise sterility, cause agents to lose potency or simply lead instruments to respond in irregular ways.

To maintain proper temperatures of devices while in transit, Cases By Source can leverage a few techniques:

  • Equip custom cases with double-wall structures that offer added insulation and protection against extreme heat exposure
  • Integrate non-hazardous and reusable phase-change materials into case walls to keep temperature-sensitive devices cool in transit
  • Top off the case with a gasketed lid that forms an airtight seal around the medical device case and keeps warm air from seeping inside the packaging

Durable Structural Protection

Medical devices are subject to a lot of forces while being transported — from the vibrations that come with bumps in the road or turbulence mid-flight to potential drops that can occur as cases are loaded and unloaded between destinations. If medical device packaging can’t withstand the impact of these forces, dents and damage on the exterior of the case can translate into potential device issues and end-user concerns over product quality.

At Cases By Source, we design and manufacture custom cases to remain safe and secure in the face of external forces. While designing custom cases to precisely fit the dimensions of your medical devices and keep them securely positioned, our extensive packaging materials and manufacturing options ensure we provide customers with the most durable (and cost-effective) packaging solution. Depending on the product in question, this could come in the form of an injection-molded plastic case, a fabricated ATA case or a molded EVA case — a choice our experts will help you make.

When a prototype of your medical device case is developed, we take the extra step to verify structural requirements are met. Third-party drop and vibration performance testing simulate the potential forces cases can experience in transit and ensure packaging is built to withstand their impact — before high-volume manufacturing of the custom cases begins.

Clear, Accurate Labeling

While labeling is important to medical devices, the same sentiment applies to their packaging. When medical devices are shipped from manufacturing warehouses to facilities, it’s critical that end-users are able to easily accept the products, and once opened, have clear documentation on how to use the device.

Cases By Source can customize medical device cases from the inside out with proper labeling. Using a range of adhesives, we can add exterior labels to your case that offer clarity around the device upon arrival to its designated location, in an impactful and aesthetically pleasing manner. Meanwhile, interior labels and packaging inserts can be incorporated into the interior of the case so device information is readily accessible and organized for the end-user.

Interested in partnering with Cases By Source for your medical device packaging? Get the conversation started, and request a free consultation.


Leave a Comment