Case Study: Disposable Product Requirements

A medium size manufacturer of disposable therapeutic products needed to retrospectively upgrade the minimal DHF for products transferred from a previously acquired small company. The company also wanted to use this as an opportunity to improve their requirements development skills.

AlvaMed supplied a team of engineers experienced in both disposable therapeutic products and requirements who were able to quickly understand the product, determine the characteristics for these type of products that needed requirements, and then write a thorough and detailed set of requirements. AlvaMed personnel worked closely with client personnel, training and mentoring them as they participated in developing the required documentation.

The resulting requirements documents were the most thorough that had ever been generated by any group at the company, establishing a higher standard of engineering excellence that met the new corporate objectives.
 

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