News & Events

April 27, 2008

Strategic partnership expands medical device software capabilities

Research Triangle Park, NC. April 27, 2009. Code Refinery, specializing in the software development used in medical device, clinical diagnostic and lab automation products which are regulated by the FDA, announced today that a strategic alliance with The Realtime Group to jointly deliver software solutions and risk-based validation testing services to clinical, medical device and pharmaceutical customers. By working together, Code Refinery and The Realtime Group, will be able to offer customers a broader scope of FDA compliant development and validation capabilities spanning from PC based applications to highly complex embedded systems used as medical devices for diagnostic and point-of-care instruments.

"Partnering with Code Refinery has enabled The Realtime Group to expand our reach to more medical device and healthcare customers. Code Refinery has built a strong reputation developing complex software applications that are not only FDA compliant but built for real world operation in the marketplace. Working with Code Refinery will bring added value to customers looking for fully documented and tested FDA compliant solutions", said The Realtime Group President, Marshall Wenrich.

"The combination of high-quality development services, particularly with embedded systems, from an experienced firm like The Realtime Group, enables us to confidently expand our capabilities and provide that value back to our customers. The significance of this partnership became validated when Code Refinery was engaged by an industry leading provider of blood testing instruments and reagents, to develop FDA compliant software for their next generation blood testing point of care device. This collaboration will be further evident as medical treatments move from the hospital to the a personalized setting with smaller, mobile devices," said Partner and Director of Business Development, Samir Dandekar.

March 10, 2008

Mi-Co Announces Strategic Alliance with Code Refinery to Deliver FDA-Compliant Software and Data Collection Solutions

Research Triangle Park, NC. March 10, 2009. Mi-Co announced today a strategic alliance with Code Refinery, a provider of FDA-compliant software and services, to jointly deliver custom software and data collection solutions for pharmaceutical, biotech and medical device customers. By working together, Mi-Co and Code Refinery will be able to offer their customers a broader range of software solutions and services and deliver additional return on investment.

November 20th, 2008

Code Refinery hosts Life Science Business Development
networking event.

Code Refinery will host a Life Science Business Development event in November at the Code Refinery offices. The event, which is also sponsored by the North Carolina Biotech Center will be attended by senior business development professionals in North Carolina’s biotechnology, pharmaceutical, diagnostic, medical device, and agricultural and veterinary organizations. For more information on attending the event, please click on the following link: LSBD November 20th Meeting (PDF)

September 10th, 2008

CED Member Spotlight: Code Refinery, LLC.

The Food and Drug Administration (FDA) approval process for products containing software used in hospitals, diagnostic labs and medical devices is challenging, complex and costly. Companies that build these innovative solutions, and their customers, cannot afford to be less than 100% certain about these systems. Code Refinery, a private, seed funded triangle-based business, gives companies focused on building medical device and clinical diagnostic solutions complete confidence in their product's software and peace of mind that it will meet the highest standards for FDA compliance. Code Refinery's software solutions save companies time and money in getting their products to the marketplace. Some local clients include Advanced Liquid Logic, Amphora Corporation, bioMérieux, LipoScience, Scynexis, Sicel Technologies, Tecan and TriPath Imaging (BD Diagnostics). More...

September 30th – October 3rd, 2007

Code Refinery to present FDA compliant product development capabilities at the 34th Annual Computers in Cardiology Conference 2007 at Washington Duke Inn, Durham, NC.

Code Refinery will give tutorials and present capabilities for FDA compliant development focused on medical devices for attendees involved in development of cardiac medical devices. Held annually without interruption since 1974, the Computers in Cardiology conference provides an international forum for scientific presentations focusing on computer applications in clinical cardiology and cardiovascular research. The conference fosters interdisciplinary discussions and collaboration between physicians, engineers, physicists, biologists, computer scientists, and others engaged in research in this area. For more information on the conference please visit http://forms.dukehealth.org/dcri/conference.nsf/cinc-fair or email us.

August 31st, 2007

Code Refinery delivers software product enhancements and verification testing for automated systems used in blood screening on time and on budget.

Code Refinery, located in Apex, NC, which provides software solutions for critical applications that are required to be FDA compliant, completed development and verification of software product enhancements for an automated system used for blood screening. In addition the development and verification testing was fully documented to meet FDA compliance requirements for medical devices used in the blood industry.

August 8th, 2007

Code Refinery celebrates the summer and success with an Island Party complete with tropical setting in 103 degree heat.

Code Refinery, located in Apex, NC, celebrated the summer and recent success with an Island Party complete with tropical setting. Everyone had a great time and tolerated the heat with ice cold beverages.

April 26th, 2007

Code Refinery hosts Life Science Business Development
networking event.

Code Refinery will host a Life Science Business Development event in April at the Code Refinery offices. The event, which is also sponsored by the North Carolina Biotech Center will be attended by senior business development professionals in North Carolina’s biotechnology, pharmaceutical, diagnostic, medical device, and agricultural and veterinary organizations. For more information on attending the event, please click on the following link: LSBD April 26th Meeting (PDF)

“We are looking forward to the opportunity to host the April meeting and provide a venue for networking with other life science and medical device professionals.”, said Samir Dandekar, Director of Business Development.

March 23rd, 2007

Bristol-Myers Squibb signs service and support agreement with Code Refinery to provide support for automated system used in the QC for infant and adult nutritional products.

Code Refinery, located in Apex, NC, which provides software solutions for critical applications that are required to be FDA compliant, will continue to provide service and support services for a turnkey system developed for Mead Johnson, Evansville, IN which was also developed by Code Refinery. The automated system is used to test the nutritional content of infant and adult products. The system was fully documented and also compliant with FDA guidelines as well as electronic signature requirements.

Click here to download the Bristol-Myers Case Study.

March 3rd, 2007

Code Refinery selected to provide development and validation services for automated systems used in blood screening.

Code Refinery, located in Apex, NC, which provides software solutions for critical applications that are required to be FDA compliant, will provide software development and validation services to add enhancements to instrument software used to automate sample preparation for infectious disease screening of blood.

March 1st, 2007

bioMerieux, Durham, NC continues relationship with Code Refinery to provide Verification & Validation services

Code Refinery, located in Apex, NC, which provides software solutions for critical applications that are required to be FDA compliant, will provide verification and validation services to bioMerieux. bioMérieux, specialized in the in vitro diagnostics sector, designs, develops, produces and markets diagnosis systems for medical or industrial applications.

January 1st, 2007

Code Refinery celebrates its 10th birthday! Code Refinery, founded in 1997, is celebrating its 10th year in business serving the life science and medical device clients.

Code Refinery looks forward to continued growth and expansion as we look ahead to the next 10 years. We want to thank all of clients for giving us the opportunity to help them solve critical problems related to FDA compliance, Software Development and Validation in Drug Discovery, Diagnostics and Food & Beverage and make a difference in their business.

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