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Customer News – $48.3 Million bioMérieux expansion adds 44 jobs

February 1, 2013 | Research Triangle Park, N.C.

Medical instruments manufacturer bioMérieux Inc. will create 44 new jobs as the company expands its Durham facility.

Partners in the project include the North Carolina Biotechnology Center, the N.C. Department of Commerce, the N.C. Community College System, Durham County and the Greater Durham Chamber of Commerce.

The announcement came earlier this week from Governor Pat McCrory and Commerce Secretary Sharon Decker.

“Companies are choosing to invest in our state because of our state’s strong workforce,” said Governor McCrory. “This announcement strengthens North Carolina’s position as a leader in bioscience and advanced manufacturing.”

The company will create 44 jobs and invest $48.3 million in Durham over the next three years. Expansion will be made possible through a performance-based grant of up to $220,000 from the One North Carolina Fund, a state grant program that promotes technology-based industries. The grant is contingent upon proof of job creation and receipt of a local funding match.

Click here to read entire story at the North Carolina Biotechnology Center

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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.

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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 www.code-refinery.com, 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 | sdandekar@code-refinery.com

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Third Annual Boston Medical Devices Summit

Mar 12, 2012 | Research Triangle Park, N.C.

Code Refinery is proud to sponsor this two-day conference, held March 6 and 7, covering issues and topics such as the following:

• Updates to the FDA’s 510(k) submission process;
• Human factors in medical device design;
• Integrating process excellence into design control;
• The Electronic Health Records and the America Invents Act;
• International regulatory concerns, and
• Strategies for bringing products to markets outside of the United States.

The meeting drew over 400 attendees and included representatives from small startups to Fortune 500 companies.

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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 www.code-refinery.com, 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 | sdandekar@code-refinery.com

Read more...


Code Refinery Celebrates Fifteen Years of Service

Jan 2, 2012 | Research Triangle Park, N.C.

Code Refinery recently celebrated fifteen years of service to industry-leading medical device and clinical diagnostic clients. Code Refinery launched in 1997 by co-founders Mike Brown and Samir Dandekar to fill an unmet need in turnkey software development services specifically for lab automation and integration. In 2004, Greg Godlevski joined the company as partner. A talented team of software analysts, developers, and testers provide additional expertise.

Today, Code Refinery is a leading OEM supplier of custom FDA-compliant software engineering services. They have developed and tested software applications used in clinical lab diagnostics, point-of-care devices, and in surgical tools for clients ranging in size from startups to major life science corporations.

Samir Dandekar, Director of Business Development, states, “Our mission is to achieve the highest standard for software quality, safety, and reliability for our clients and their customers. We are taking steps to continuously improve our process and our quality system will be ISO 13485 and 9001 certified by the end of March 2012. We are thankful to our customers and employees to have served the medical device and clinical diagnostic community for the past fifteen years.”

For project highlights throughout the years, see Customer Success.

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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 www.code-refinery.com, 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 | sdandekar@code-refinery.com

Read more...

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