QUALITY MANAGEMENT & CERTIFICATES
Committed to maintaining the highest quality standards.
QUALITY
PUT YOUR PRODUCT IN THE MOST RELIABLE HANDS
At BGS, we use a stringent and sophisticated quality management system that we continually improve to best serve customers like you. Our system defines guidelines and rules for routine tasks, maintaining and enhancing processes, and ensuring the transparency of our manufacturing and inspection operations.
When we begin operations in mid-2025, our quality system will meet the medical device sterilization requirements of ISO 9001, ISO 13485, and ISO 11137.
MEETING THE HIGHEST STANDARDS
QUALITY MANAGEMENT AT BGS
Adhering to the highest quality standards in compliance with strict regulatory requirements is an essential part of our service. Our highly automated processes are designed to meet the requirements of the most rigorous international quality standards. Through the consistent application of our quality management system, all processes are designed to achieve reliable and reproducible results.
The radiation process
reproducible Technology
The technology we use, combined with precise coordination of the processes, makes it possible to offer irradiation services in a repeatable manner. To ensure full traceability, all orders from receipt of goods through the irradiation process to delivery are recorded and retained in accordance with all regulatory requirements.
RADIATION PROTECTION
DOING EVERYTHING POSSIBLE TO ENSURE SAFETY
As operators of electron accelerators, we are committed to protecting human health and the environment. This commitment includes meeting the highest safety standards and using extensive monitoring technology. Our facilities are constructed to prevent our team members and the environment from experiencing radiation exposure.
To ensure the safe use of our technology, team members undergo training regularly. In addition, our site is inspected continuously by the Pennsylvania Department of Environmental Protection (DEP).