About Boulder Package Testing
A contract medical device package validation lab, part of the Boulder BioMed family of companies.
Our Mission
Boulder Package Testing exists to give medical device manufacturers an expert partner for package validation without the round trips. We execute ISTA-aligned test methods and ISO 17025-aligned protocols under the Boulder BioMed ISO 13485 quality management system. Our unique advantage is co-location with Boulder Sterilization — the only US arrangement where EO and chlorine dioxide sterilization and package testing operate on the same campus.
This means devices move from sterilization to distribution simulation, accelerated aging, and integrity testing without ever leaving our chain of custody. One protocol, one report, one quality system — the way package validation should work.
Leadership
Jim Kasic
Founder & Principal — AAMI Certified Industrial Sterilization Specialist
Jim Kasic is the founder of the Boulder BioMed family of companies and an AAMI Certified Industrial Sterilization Specialist. With decades of experience in medical device manufacturing, sterilization, and quality systems, Jim established Boulder Package Testing to give medical device companies the only US lab co-located with EO and chlorine dioxide sterilization — eliminating the round trips, re-sterilization risk, and broken chain of custody that have long defined contract package validation.
Jim's expertise spans the full lifecycle of medical device commercialization, from design and manufacturing (Boulder iQ) through regulatory and quality consulting (Boulder RA/QA), biological testing (Boulder BioLabs), and sterilization (Boulder Sterilization). This integrated perspective ensures that package validation programs are designed with the full regulatory and manufacturing context in mind.
Read Jim's full bio →Location & Contact
Address
5375 Western Ave.
Boulder, CO 80301
United States
Contact
Phone: 303-531-1238
Email: info@boulderpackagetest.com
Quality System
Boulder Package Testing operates under the Boulder BioMed ISO 13485 quality management system. All equipment is calibrated, all methods are procedure-controlled, and all testing is performed by trained personnel with documented competency. We are pursuing ISO 17025 accreditation and ISTA certification to further formalize our testing laboratory quality system.
The Boulder BioMed Family
Five companies, one campus, one quality system.