Requirements management in medical device

Rami.Azulay May 10th, 2012 Posted by Rami Azulay( ) Requirements Management

Medical device industry

The medical device industry is a rapid-growing industry, and so is the complexity of device technology. Medical device corporate chemical and biological ingredients and can also combine a complex mechanisms and electronic systems. Operating such systems requires complex software.

The challenge in developing medical device

Many questions are raised planning and developing such software: What should it do? How can we validate its operation? How can we predict the required effort estimation and how can we track its progress as time pass? The medical device must operate in high-level accuracy of thousandths of an inch, and measured in nanoseconds.

Market requirements

The goal of this module is to gather all the requirements of the device. The process of gathering requirements for a new device, or application is one of the most important phases in the development process. In order to meet company goals, these requirements must reflect customers and end users needs as well as company requirements. Market requirements come from multiple sources, such as company documentations, competitors, domain experts, marketing department and prospective users.

Gathering data from multiple resources demands a systematic process. QPack Medical MRD provides a structured system for collecting data from them, synthesizing, and then rationalizing and reducing the data. This last step is needed to remove conflicting or redundant requirements, and eliminate or annotate those requirements that are impractical based on current technology, cost constraints, or market factors.

Last stage in this process is to trace these requirements and verify they are delivered.

QPack requirements management

QPack requirements management creates a central information repository, which includes all requirements data, such as description, attributes, status information, and other information. Requirements and their associated attributes can evolve, be adapted, and be reused for subsequent development projects, lowering the overall development cost. This repository not only defines the specifics of what the system should do, it assists managers in set priorities and effort estimation, and provides up-to-date information of project progress.

QPack systematic approach allows organizing, documenting, and managing both the initial and the changing requirements of a system. A primary result of this effort is the development of one or more requirements specifications that define and document the complete behavior of the system. It allows better definition and management of the labeling claims, allows better control of the project, improve quality by combining the validation phase into the process and allows each participant in the process to understand what he should deliver. By improving team communication, and provide professional tools, Project cost is reduce significantly.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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