Jim Kasic — Founder & CEO, Boulder BioMed
Founder and CEO of the Boulder BioMed family of companies.
About Jim
Jim Kasic is the founder and CEO of the Boulder BioMed family of companies, including Boulder RA/QA, Boulder iQ, Boulder Sterilization, Boulder BioLabs, and Boulder Package Testing. He has led the development of more than two dozen medical devices across orthopedic, cardiovascular, in vitro diagnostic, and surgical categories, and has authored ISO 13485-compliant quality management systems for manufacturers ranging from early-stage startups to established OEMs. Jim holds deep expertise in FDA regulatory strategy and submissions (510(k), De Novo, PMA, and Pre-Submission), EU MDR/IVDR technical documentation, sterilization, and medical device quality systems. He is a member of AAMI and a frequently published voice on medical device regulatory and quality topics.
Areas of Expertise
- · FDA regulatory strategy & submissions
- · 510(k), De Novo, PMA, Pre-Sub
- · ISO 13485 quality management systems
- · FDA QMSR transition
- · EU MDR / IVDR technical documentation
- · Medical device audits & inspections
- · EO & chlorine dioxide sterilization
- · Medical device development & manufacturing
Affiliations
Member, Association for the Advancement of Medical Instrumentation (AAMI).
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