Boulder BioMed Earns ISTA Certification for Package Testing Lab

-- Vertical integration across med device product development services speeds time to market --

BOULDER, Colo., Nov. 3, 2026 /PRNewswire/ -- Boulder BioMed has earned certification from the International Safe Transit Association (ISTA) for its package testing lab.

Boulder Package Testing is a contract medical device package validation lab executing ISTA-aligned test methods and ISO 17025-aligned protocols. Testing services include:

• Integrity testing: dye penetration, bubble leak, visual inspection
• Seal strength and burst testing
• Distribution testing: ASTM D4169 or applicable ISTA testing
• Aging/shelf life testing: accelerated aging and real-time aging

Vertical integration for med device development
As a member of the Boulder BioMed family, the lab serves as a key component in the company's comprehensive vertically integrated suite of services for medical device development. Boulder BioMed offers full product development services for medical devices.

This makes Boulder Package Testing the only U.S. package testing lab co-located with the full array of services: design, engineering, manufacturing, sterilization (both ethylene oxide and chlorine dioxide), regulatory affairs and quality assurance, and microbiology testing. From a package perspective, devices move efficiently from sterilization to distribution simulation, accelerated aging and integrity testing, working with one protocol and one quality system.

Unbroken chain of custody reduces or eliminates risks of vendor handoffs
With ISTA certification, Boulder BioMed will now use Boulder Package Testing for all projects unless the client requests otherwise, says Jim Kasic, president and CEO. "The unbroken chain of custody that we can offer developers – from design, regulatory work and manufacturing all the way through sterilization and on to market – is unparalleled."

Medical device developers often rely on different partners for design, manufacturing, packaging validation, sterilization and regulatory submissions, Kasic explains. While each vendor may do its job correctly, critical responsibilities can fall through the gaps that occur during product handoffs.  

Vendor handoffs carry hidden risks, he says. "With full co-location services, now including the ISTA-certified package lab, we can significantly reduce or eliminate these risks." The bottom line for the developer, he adds, "is faster time to market with fewer worries and less stress." Kasic details the issues in working with multiple vendors in a new video: The Hidden Cost of Vendor Handoffs.

Boulder BioMed (www.boulderbiomed.com)
Boulder BioMed is a family of expert contract consulting firms that provides life sciences companies all the resources they need to bring products to market. Boulder BioMed provides a single source for device developers, providing full product development under one roof: ideation, design, engineering, manufacturing; sterilization; regulatory affairs and quality assurance; package testing; and microbiology testing.

Boulder BioMed is based in Boulder, Colorado, and is ISO 13485-certified, with packaging testing, including shipping validation, per ASTM D4169 and ISTA 3A.

Media contact: Aimee Bennett, [email protected], 303-843-9840

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SOURCE Boulder BioMed