Jim Kasic — Founder, Boulder Package Testing

About Jim

Jim Kasic is the founder of Boulder Package Testing and CEO of the Boulder BioMed family of companies. He has designed medical device packages for more than two dozen products across orthopedic, cardiovascular, in vitro diagnostic, and surgical device categories. Jim has authored ISO 13485-compliant quality management systems for medical device manufacturers ranging from early-stage startups to established OEMs, and holds deep expertise in sterile barrier system design, ISO 11607 validation, and medical device regulatory affairs. He is a member of AAMI and has extensive experience navigating FDA 510(k) submissions and CE technical file reviews for Class II medical devices.

Areas of Expertise

• · Sterile barrier system design
• · ISO 11607-1 / -2 validation
• · ISO 13485 quality management systems
• · FDA 510(k) submissions
• · CE technical file review
• · Class II medical device regulatory affairs
• · EO sterilization
• · Chlorine dioxide sterilization
• · Medical device packaging design
• · Distribution simulation (ISTA 3A, ASTM D4169)

Affiliations

Member, Association for the Advancement of Medical Instrumentation (AAMI).