About Boulder RA/QA
More expertise. Specialized knowledge. Better results — from consultants who run the operations they help you pass.
Who We Are
Boulder Regulatory Affairs and Quality Assurance (Boulder RA/QA) provides full regulatory and quality support for medical devices and in vitro diagnostic products. Since 2009, our experts have helped companies navigate the process of getting devices to market quickly — through FDA submissions, ISO 13485 quality systems, audits and remediation, and international compliance. We are part of the Boulder BioMed family, a group of expert contract firms that together provide everything a device company needs to reach market under one roof.
What Makes Us Different
We live it. Most regulatory and quality consultants advise from the outside. We are part of an FDA-registered operation that designs, manufactures, sterilizes, packages, and tests medical devices every day. The submissions we write are backed by data our own family generates. The quality systems we build are the same kind we run and get inspected on. We are not talking heads in a basement — we live the requirements we help you meet.
We know audits from both sides. A typical device company faces an external audit about once a year. As FDA-registered establishments, our own customers audit us several times a month. We sit in the auditee’s chair constantly, so we prepare you for inspections from genuine, current, two-sided experience.
We lead on AI. Our AuditIQ tool brings AI to QMS review and audit readiness — modern methods backed by experienced human judgment. We believe a medical device quality practice should put AI to work on the slow parts of compliance, without ever taking the expert out of the loop.
An Engineering Mindset
We are laser-focused on identifying bottlenecks and solving problems with maximum detail and efficiency. We offer comprehensive expertise and full capabilities under one roof, and we partner with you through the entire process — from classification through clearance and beyond — with customized service designed to get you to market as quickly as possible.
Quality & Registrations
Boulder RA/QA operates under an ISO 13485 quality management system. Within the family, Boulder iQ and Boulder Sterilization are FDA-registered establishments. That registration is not a marketing line for us — it is why we know, first-hand, what an FDA investigator looks for on the floor.
Meet the Founder
Jim Kasic founded Boulder BioMed and leads the family of companies. Learn about his background in medical device regulatory affairs, quality systems, and device development.
About Jim Kasic →The Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.