BGS US, a provider of radiation sterilisation for medical devices, pharmaceutical packaging, and biotechnology products has recently acquired quality certifications for ISO 13485 and ISO 9001, and the confirmation of ISO 11137 for its 100,000-square-foot Electron Beam (E-Beam) sterilisation facility in Imperial, PA, near the Pittsburgh International Airport. 

The facility will begin operations in mid-2025. The certification audit was conducted by DQS Medizinprodukte GmbH from January 7-10, 2025, and verified that BGS US meets all requirements without any non-conformities.

“This significant milestone marks a crucial step for our company and underscores our commitment to the highest levels of quality and customer satisfaction. It also keeps us on schedule to begin operations as planned,” says Leonard Zuba, General Manager, BGS US. 

ISO 13485 is a globally recognised standard for medical device quality management systems, ensuring that products meet stringent safety and performance requirements and ISO 9001 confirms that a company’s quality management system adheres to international best practices and supports operational efficiency and continuous improvement.

Whereas, ISO 11137 specifies requirements for the development, validation, and control of radiation sterilisation processes that ensure the highest levels of safety and efficacy for the use of medical devices.

To maintain certifications and ensure continuous improvement, BGS US will undergo annual compliance audits. The next one is scheduled for January 2026.