Case Study: Software Requirements

A medium size medical device manufacturer of mostly disposable products had purchased the rights to an FDA cleared diagnostic monitoring device and hired a small software development group to work on a major software upgrade, which took several years. The 510(k) was rejected by the FDA because the submission for this medium risk device had not included the required design control documentation, including software requirements specifications, software design specification, and design verification reports. The software development group was unfamiliar with the application of design controls to software-containing products, did not have adequate documentation to submit, and did not know what exactly what was needed.

AlvaMed supplied a team of engineers experienced in both software development and requirements who were able to quickly understand the product, assess the materials that were available, and then write a thorough and detailed set of requirements and design specifications, as well as design verification and design validation protocols. AlvaMed also led the software hazards analysis that was requested by the FDA. AlvaMed personnel worked closely with client personnel, training and mentoring them as they participated in developing the required documentation.

Upon resubmission of the 510(k), the device was promptly cleared with no further issues or requests for information.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control