Code Refinery Awarded ISO 13485 and ISO 9001 Certification of Registration

May 21, 2012 | Research Triangle Park, N.C.

Code Refinery, a custom software company, announces its ISO 13485 and ISO 9001 certificate of registration. The certification was awarded by Underwriters Laboratories for the provision of the design and development of software for use in medical, laboratory, and in vitro diagnostic devices. This achievement marks the successful completion of an independent evaluation of Code Refinery’s quality management system, which is deemed in compliance with the ISO standards.

Underwriters Laboratories is an internationally-recognized independent safety-science company that assesses management systems and provides product safety services and certifications.

View Code Refinery’s ISO certificates here.

Samir Dandekar, Director of Business Development, states, “Our mission is to achieve the highest standard in software quality, safety, and reliability for our clients and their customers. Achieving ISO 13485 and 9001 certification is a major accomplishment for our company and confirms our position as a solid development partner. It also highlights our commitment to keep patient safety and product quality a deep-rooted part of our company culture.”

Code Refinery recently celebrated fifteen years of serving medical device and clinical diagnostic instrumentation manufacturers. The company launched in 1997 to fill unmet needs in turnkey software development specifically for lab automation and integration. Since its establishment, Code Refinery has cultivated a thorough understanding of medical device software requirements and has consistently provided world-class FDA-compliant software development services to medical device and clinical diagnostic industry leaders.


Code Refinery is a privately-held custom medical device software development company serving medical device and life science clients. As a leading OEM supplier of custom FDA-compliant software products and services, Code Refinery has developed and tested software applications used in clinical lab diagnostics, point-of-care devices, imaging and surgical tools for clients ranging in size from startups to major life science corporations.

Visit Code Refinery at, follow us on Twitter for up-to-date software development news, or connect with our company and staff on LinkedIn and Facebook.

Media Contact:
Samir Dandekar

Director, Business Development
2201 Candun Drive, Suite 201, Apex, N.C. 27523
919–696–4745 |

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