Boulder Sterilization Announces ISO 13485:2016 Certification

-- Milestone underlines commitment to quality for chlorine dioxide sterilization --

BOULDER, Colo., Aug. 26, 2025 /PRNewswire/ -- Boulder Sterilization, part of the Boulder BioMed family, has received 13485:2016 certification from the British Standards Institute (BSI) for its chlorine dioxide service.

The certificate confirms that the company operates a quality management system that complies with the requirements of ISO 13485:2016 for its chlorine dioxide (CD) sterilization. The company previously obtained 13485:2016 certification for its ethylene oxide sterilization service.

"The ISO certification is a major step confirming our commitment to providing CD sterilization service of the highest quality," says Jim Kasic, president and CEO of Boulder BioMed. "Meeting the BSI rigorous global standards demonstrates our focus on quality and regulatory excellence as we work to help medical device developers speed their products to market."

Boulder Sterilization offers quick-turn service with both EO and CD sterilization. It is currently the only U.S. company to offer the combination of clean room final assembly, packaging and quick-turn sterilization with in-house biological testing.

• Sole contract sterilizer offering both EO and CD technologies
• World's largest contract CD sterilizer
• Quick-turn service for all batch sizes
• Expedited service for urgent and immediate-requirement projects

ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. Developed by the International Organization for Standardization to ensure the safety and effectiveness of medical devices, it builds on the ISO 9001 standard with additional regulatory requirements specific to medical devices. In 2024, the U.S. Food and Drug Administration issued the Quality Management System Regulation Final Rule, which harmonizes U.S. requirements with global standards through the adoption of ISO 13485 for medical devices. ISO 13485 is also widely used in the European Union.

Boulder Sterilizations (www.bouldersterilization.com)
Boulder Sterilization, which offers both quick-turn ethylene oxide and chlorine dioxide sterilization, is part of the Boulder BioMed family, a group of expert contract consulting businesses providing all the services life sciences companies need to get their products to market. Boulder BioMed provides a single source for device developers, providing full product development under one roof: ideation, design, engineering, manufacturing, sterilization and packaging, and regulatory affairs and quality assurance.

Boulder BioMed is based in Boulder, Colorado, and is ISO 13485-certified. Packaging testing, including shipping validation, follows ASTM D4169 and ISTA 3A guidelines and procedures.

Media contact: Aimee Bennett, [email protected], 303-843-9840

SOURCE Boulder Sterilization