Our Commitment to Quality and Compliance
Raising the standard in safety and reliability
Quality Commitment
At Alpha-Omega Services, Inc. (AOS), quality is the foundation of everything we do. Whether manufacturing our proprietary brachytherapy applicators and accessories, providing contract manufacturing of sealed sources, or producing Type B radioactive material transportation casks, we adhere to strict regulatory and quality standards to ensure safety, compliance, and reliability.
Regulatory Commitment
AOS operates under a certified International Standard Organization for Standardization (ISO) 13485:2016 Quality Management System (QMS) to maintain the highest standards in medical device manufacturing. We are fully committed to compliance with FDA, NRC, and DOT regulations, as well as adherence to ISO 13485:2016 and other industry standards. We continuously monitor industry changes to stay aligned with the latest requirements.
Our Standards
Sealed Source Contract Manufacturing
AOS manufactures and distributes sealed brachytherapy sources for industry leaders, following strict regulatory and quality requirements:
FDA Regulations
- 21 CFR Part 820
- 21 CFR Part 801
NRC & DOT Regulations
- 10 CFR Part 21
- 10 CFR Part 71
- 49 CFR Part 172
State Regulations
- LAC Title 33 Part XV
- LAC Title 33 Part V
International & Industry Standards
- ISO 13485:2016 (Certified QMS)
- ISO 14971:2019 (Risk Management)
- ISO 2919:2012 (Sealed Source Classification)
- ISO 9978:2020 (Sealed Source Leak Testing)
- IAEA SSR-6:2018 (Radiation Safety)
- IATA Dangerous Goods Regulations
AOS Brachytherapy Applicators & Accessories
We design and manufacture a proprietary line of FDA-cleared brachytherapy applicators and accessories, ensuring compliance with:
State Regulations
California Code of Regulations, Title 17, §10376 (2024)
Quality & Risk Management Standards
- ISO 13485:2016 (Certified QMS)
- ISO 14971:2019 (Risk Management)
AOS Type B Transportation Casks
AOS manufactures Type B radioactive material transportation casks, meeting NRC certification requirements and international safety standards, including:
Quality Assurance Requirements
10CFR Part 71 Subpart H
10CFR Part 50 Appendix B
USNRC Regulatory Guide 1.28
USNRC Regulatory Guide 7.10
NUREG/CR-6407
ASME NQA-1
ANSI N45.2
Industry & International Standards
IAEA TS-R-1
IAEA TS-G-1.1 (ST2)
ISO 17025:2015
NEI 14-05
Commitment to Quality & Safety
AOS upholds rigorous quality control, testing, and validation processes to ensure the highest standards of safety and reliability. Our FDA, NRC, and DOT-compliant manufacturing and transportation solutions undergo comprehensive verification, validation, and continuous improvement initiatives to meet both regulatory and customer expectations.
Why Choose AOS?
End-to-End Expertise
AOS provides complete solutions for medical devices and nuclear material handling, from design and manufacturing to regulatory compliance and logistics.
Regulatory Trust
We have decades of experience in seamless compliance with FDA and NRC regulations as well as ISO standards.
Customer-Centric Approach
Our customized solutions are backed by a dedicated team of industry experts offering regulatory guidance and technical support.
At AOS, quality isn’t just a goal — it’s our standard.
A Mark of Trusted Quality
AOS holds an NQA Global Assurance certification, reinforcing our dedication to safety, compliance, and superior product reliability.
