Oligo Factory proudly announced today that our Holliston, MA facility has received ISO 13485:2016 certification, marking a significant milestone in our dedication to supporting clients across industries, including molecular diagnostics (MDx).

Commitment to Quality and Compliance

ISO 13485:2016 is an internationally recognized standard for quality management systems specific to the medical device industry, including in vitro diagnostic (IVD) products. This certification confirms that Oligo Factory meets the stringent requirements necessary to manufacture oligonucleotides to be further incorporated into diagnostic assays. Our compliance with ISO 13485 ensures that every product we deliver—primers, probes, and other essential oligonucleotides—meets the highest standards of quality and reliability.

Enhancing Customer Trust

Chris Boggess, CEO of Oligo Factory, Inc., highlighted the significance of this certification: “With ISO 13485 certification, customers can further trust in the reliability and consistency of our products, empowering them to drive advancements in diagnostics and personalized medicine. Our customers can be confident that partnering with Oligo Factory means receiving high quality, reliable products that support their innovative work in diagnostics and therapeutics.”

Expanding Capabilities and Facilities

Founded in 2006, Oligo Factory has evolved to meet the growing demands of the life sciences industry. In 2023, we relocated to a brand new purpose-built facility designed to increase our production capacity and enhance our ability to serve our clients better. This facility upgrade, coupled with our recent GMP ICH Q7 compliance, underscores our commitment to continuous improvement and excellence in all aspects of our operations.

Supporting the Entire Product Lifecycle

The attainment of ISO 13485 certification represents a crucial step in our ongoing mission to support clients from concept through commercialization. Whether developing new diagnostic assays or scaling up production for clinical applications, Oligo Factory is equipped to provide the high-quality oligonucleotide solutions necessary for success. Our robust quality management system ensures that we can promptly and effectively address customer needs, providing unparalleled support throughout the product lifecycle.

Global Market Access and Innovation

The international acceptance of ISO standards facilitates smoother regulatory approvals and market entry, enabling our customers to expand their reach and impact worldwide. By adhering to these rigorous standards, Oligo Factory ensures that our customers can focus on innovation, confident in the reliability and consistency of our products.

We are proud of this significant achievement and look forward to deepening our support for clients across molecular diagnostic, therapeutic and life science industries globally.

Learn more about Oligo Factory’s commitment to Quality