Boulder Sterilization Achieves ISO 13485:2016 Certification
Boulder Sterilization Achieves ISO 13485:2016 Certification
-- Milestone underlines commitment to quality for chlorine dioxide sterilization --
Boulder Sterilization, part of the Boulder BioMed family, has recently accomplished a significant milestone by obtaining the ISO 13485:2016 certification from the British Standards Institute (BSI) for its chlorine dioxide sterilization service. This prestigious certification highlights Boulder Sterilization's commitment to quality and excellence in its operations.
The ISO 13485 certificate confirms that Boulder Sterilization maintains a robust quality management system that meets the requirements for chlorine dioxide (CD) sterilization. This accreditation follows the company’s earlier certification for its ethylene oxide (EO) sterilization service, further establishing its credibility in the field.
Jim Kasic, the president and CEO of Boulder BioMed, expressed pride in this achievement, stating, "The ISO certification is a major step confirming our commitment to providing CD sterilization service of the highest quality. Meeting the BSI's 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 is known for offering quick-turn services utilizing both EO and CD sterilization methods. As the only company in the U.S. providing the combination of clean room final assembly, packaging, and quick-turn sterilization accompanied by in-house biological testing, it stands out in the industry.
Key Features of Boulder Sterilization Services
Here are a few important highlights regarding Boulder Sterilization’s offerings:
- The sole contract sterilizer in the U.S. offering both EO and CD technologies.
- The world's largest contract chlorine dioxide sterilizer.
- Quick-turn service available for all batch sizes.
- Expedited service for urgent projects and immediate needs.
ISO 13485 is an internationally recognized standard designed to implement quality management systems specifically for medical devices. Developed by the International Organization for Standardization, it ensures safety and efficacy through compliance with additional regulatory requirements beyond the existing ISO 9001 standard.
In 2024, a significant regulatory advancement was undertaken when the U.S. Food and Drug Administration issued the Quality Management System Regulation Final Rule. This rule harmonizes U.S. requirements with global standards by adopting ISO 13485 for medical devices, gaining widespread acceptance in the European Union as well.
About Boulder Sterilization
Boulder Sterilization offers quick-turn ethylene oxide and chlorine dioxide sterilization services and operates within the Boulder BioMed family. Boulder BioMed encompasses a collection of specialized contract consulting businesses that provide all essential services required by life sciences companies to facilitate market entry.
With a commitment to excellence, Boulder BioMed delivers a comprehensive suite of services to device developers. This includes full product development under one roof, covering ideation, engineering, manufacturing, sterilization, packaging, as well as regulatory affairs and quality assurance. The firm is committed to ensuring that all processes comply with industry standards, particularly through ISO 13485 certification.
Boulder BioMed is headquartered in Boulder, Colorado, and adheres to top industry standards in its operations. Its packaging testing aligns with ASTM D4169 and ISTA 3A guidelines to ensure optimal product safety and integrity.
For media inquiries, please contact Aimee Bennett at 303-843-9840.
Frequently Asked Questions
What is the significance of the ISO 13485:2016 certification?
The ISO 13485:2016 certification signifies that Boulder Sterilization adheres to high standards for quality management in the medical device industry.
What services does Boulder Sterilization provide?
Boulder Sterilization offers both quick-turn ethylene oxide and chlorine dioxide sterilization services, along with in-house biological testing.
Why is Boulder Sterilization unique in its offerings?
It is unique as the only U.S. company offering a combination of EO and CD sterilization, alongside clean room assembly and packaging services.
How does ISO 13485 benefit medical device developers?
ISO 13485 provides a framework that enhances product safety and compliance, allowing developers to bring their products to market more efficiently.
What role does Boulder BioMed play in the life sciences sector?
Boulder BioMed offers a one-stop solution for life sciences companies, providing comprehensive services from product development to regulatory compliance.
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