Services

Northfield Medimation utilizes a systematic, documented approach to the development of equipment. Our development process ensures that the client’s requirements are documented, implemented and tested. This testing can be further used to support and reduce our client’s own internal qualification and validation requirements.

The first step in our process is documenting the client’s requirements and intended use. Those high level requirements are then transformed into specifications that are used to generate the design. Design reviews are held and documented to ensure the design meets our client’s needs. As the equipment is being designed, test protocols are generated that will be used to verify the equipment meets the stated requirements. A trace matrix ensures that all specifications have associated tests. Before the equipment leaves the factory, the test protocols are executed and the results documented. When the equipment meets our quality control requirements, it is ready to be shipped to the client’s facility.

The benefit of our approach to equipment development is the ability to deliver solutions with superior quality and value, and with a high level of confidence that the system meets the client’s specifications.

Medimation has a thorough understanding of equipment validation requirements and therefore can offer a variety of services to support our client’s quality system needs. The services Northfield Medimation offer include:

· Providing documentation in Northfield Medimation’s format

· Providing a complete validation documentation package

· Supporting validation up through execution of qualification protocols