The success of any program is often determined by the upfront organization and planning activities. Because Quest develops medical and non-medical devices for their clients, the degree of planning is appropriately tailored to the program while maintaining the essential elements of good engineering. The following are some of the elements that are often created during the project planning stage:

Project Planning

In the project planning phase Quest will create a document called the Product Development and Quality Plan (PDQP). The PDQP essentially identifies how the various elements of the Quality System Regulations (QSR) will be fulfilled for medical devices. For non-medical applications it basically outlines the essential steps in the development process and identifies the documents that will go into the design history file. The plan would include a table outlining the various design elements and documents, the individual responsible for their creation, who is responsible for their review, how the documents will be controlled, how they will be approved and by whom. Within the table would be represent the combined Client-Quest team. The Client plays an important part in the creation of this table. The plan would also identify how audits are conducted and how revisions of the documents are to be controlled.

Requirements Definition

A vital part of any successful development activity is developing and understanding the needs of the customer. Functional requirements will be identified that would become the basis for development, verification, and testing of the resultant product. The Client plays a vital part in this process and they often represent the voice of the customer or brings representative customers to the process. The requirements once complete would be reviewed as outlined in the PDQP.

Risk Analysis

The development of a medical device requires the creation and ongoing management of a risk analysis. Often this is done in conformance with the ISO-14971 standard. The risk analysis is initially based on the requirements and other information known about the future product. It is within the Risk Analysis that the various consensus standards might be identified that the product would comply with in order to mitigate risks. For example, the risk of patient electrical shock could be mitigated by compliance with the 60601-1 standard. The risk analysis once complete would be reviewed as outlined in the PDQP.