Boulder Sterilization Achieves Prestigious ISO 13485:2016 Certification for Quality Management

Boulder Sterilization Secures ISO 13485:2016 Certification

Boulder Sterilization, a prominent company in the medical sterilization sector and a proud member of the Boulder BioMed family, has officially announced that it has achieved the highly coveted ISO 13485:2016 certification. This milestone was awarded by the British Standards Institute (BSI) and signifies Boulder Sterilization's unwavering commitment to providing top-tier chlorine dioxide (CD) sterilization services.

The ISO certification serves as a clear acknowledgment that the company's operations are anchored in a rigorous quality management system, which aligns with the specific demands set forth by the ISO 13485:2016 standards. This certification not only emphasizes the effectiveness of Boulder Sterilization's chlorine dioxide sterilization processes but also supports its historical compliance with similar standards for ethylene oxide (EO) sterilization services.

Jim Kasic, President and CEO of Boulder BioMed, expressed his enthusiasm regarding this achievement, stating, "The ISO certification is a major step confirming our commitment to providing CD sterilization services of the highest quality. Meeting BSI's rigorous global standards demonstrates our focus on quality and regulatory excellence as we work to assist medical device developers in expediting their products to market."

Industry Leader in Sterilization

Boulder Sterilization has distinguished itself as an industry leader, being recognized as the world's largest contract CD sterilizer. The company offers rapid turnaround services for its sterilization processes, ensuring that clients' needs are met promptly, regardless of batch sizes. With the dual capabilities of EO and CD sterilization, Boulder Sterilization is uniquely positioned in the market, providing clients with not just sterilization, but also clean room assembly, packaging services, and in-house biological testing—all from one source.

This comprehensive service approach is particularly beneficial for medical device manufacturers seeking a streamlined process to bring their products seamlessly to market. The dual certification simplifies the regulatory pathway, allowing clients to navigate the complexities of compliance with greater ease.

Importance of ISO 13485

ISO 13485 is an internationally recognized benchmark for quality management systems specifically within the medical device industry. It extends the general quality assurance framework provided by ISO 9001 by incorporating stringent regulatory requirements tailored for medical devices. This certification is not only important for companies in the United States, especially following the U.S. Food and Drug Administration's (FDA) Quality Management System Regulation Final Rule, but it is also critical for compliance within the European Union.

Boulder Sterilization's adherence to ISO 13485 guarantees that its practices meet global standards for safety and efficacy in medical device manufacturing. The company encourages device developers to leverage their ISO-certified services to ensure their products meet or exceed quality expectations in the marketplace, establishing a benchmark for reliability.

In conclusion, Boulder Sterilization's achievement of the ISO 13485:2016 certification marks not just a critical moment in the company’s history but also signifies its enduring commitment to quality and excellence in the field of medical sterilization. As the company continues to expand its services, clients and partners can rest assured that Boulder Sterilization will maintain the high standards that have become synonymous with its name.

For more details about Boulder Sterilization and its services, visit their website at bouldersterilization.com.