Boulder BioMed Achieves ISTA Certification for Package Testing Lab
Boulder BioMed's package testing laboratory has received certification from the International Safe Transit Association (ISTA), enhancing the company's vertically integrated medical device development services.
Boulder BioMed has secured ISTA certification for its package testing facility in Boulder, Colorado. The laboratory performs validation testing for medical device packaging, utilizing protocols aligned with both ISO 17025 and ISTA standards, including integrity, leak, and distribution testing.
This certification allows the company to incorporate package testing into its comprehensive suite of product development services. By co-locating design, manufacturing, sterilization, and regulatory compliance under one quality system, Boulder BioMed aims to streamline the development process for medical device manufacturers.
CEO Jim Kasic stated that this integrated approach is intended to mitigate risks associated with handing off projects between multiple specialized vendors. By maintaining an unbroken chain of custody, the company seeks to reduce operational complexity and accelerate the timeline for bringing medical devices to market.