Code Refinery What we offer


















Risk Management/Design/Development

Our strong working knowledge of medical devices and lab instrumentation allows us to tackle the challenges of combining hardware and software for critical applications. Depending on your needs, Code Refinery can design and build your software system from concept to compliance to product launch.

Risk Management

At Code Refinery, we believe that risk management must begin at the ground level of a project. Our risk management process consists of identifying, assessing and controlling hazards associated with a system, ultimately showing traceability as to how each hazard was mitigated. While risk management is tailored to meet each specific situation, it is always our goal to contain hazards to acceptable levels. We formally analyze, evaluate and control the risk.

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Design

Our design practice involves working with you to engineer the blueprint for your software. Code Refinery utilizes a proven methodology to design a system that will meet user, technical, regulatory and quality specifications and requirements in order to prevent costly modifications during software development.

Development

Once the blueprint for your software has been created, our engineers build the product, making sure that the well-thought-out design does not get lost in implementation. We accomplish this through documented technical reviews at every phase, where we analyze the construction and confirm that it meets the design.

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Facts

The FDA determined that 40% of medical device recalls were attributable to design defects.

“FDA analyzed 3140 medical devices from 1992 to 1998 and discovered that 242 device recalls (7.7%) are attributable to software failures. Of those software related recalls, 192 (79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution.”

Source: Guidance for Industry and FDA Staff, General Priniciples of Software Validation, January 11, 2002.



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