Project Scoping for Medical Device Testing

Are you ready for the testing and certification process? – Part 3

Over the last couple of months UL has discussed solid ways to plan for compliance. In our third installment of our testing and certification process series, we will discuss the importance of the project scoping phase. While each project is unique, they all go through the same basic phases. While project scoping may appear to be the simplest phase, it is critical to pay close attention to the details communicated.

Project scoping details

During project scoping, an engineer will review all the details provided in the quote and confirm the services and deliverables you requested. The project scope letter will communicate the following:

Model identification - Confirm the models and part numbers noted in the scope letter to match the models you want to appear in the reports. If the model is going to change, we need to know that to ensure the final report includes the correct model. For example, sometimes a project starts with a temporary model name/number.

Relevant standards - The scope letter will outline the exact standards* that will be used during the investigation. Confirming the standard details match remains critical, different versions of standards can have different requirements. *exact standard includes edition, issue/revision date and amendments.

Deliverables – Confirm the services and deliverables to be provided to you as a result of the project. The project scope could be anything from a simple letter report reviewing the device to specific clauses in standards to a full evaluation resulting in issuance of the UL Mark and IECEE CB Scheme Certificate. It is critical to understand exactly what is needed to ensure everyone is working towards the same goal.

Necessary starting items – This list is developed specifically for you based on your product and the deliverables requested and highlights the minimum number of items required to start the investigation. Typically, customers request additional items throughout the project.

Estimated project turnaround time -- The time frame it will take to complete the project once you provide all the requested information and/or samples. The estimated turnaround time may be adjusted based on delays in receiving information, test or construction issues, retesting, etc. To fully understand the time frame, communication with your project handler is key. The project handler will be able to identify critical path items to keep the project on schedule.

Once you have confirmed the above is correct and provide the requested items, the project will then be assigned to an engineer to start the work. If you have any questions concerning the received scope letter, contact the engineer. If the items requested are delayed, please contact the engineer or project handler to discuss alternatives. In many instances, we can begin with less than all the requested items.

In all phases of the project, communication with the engineer is critical. In upcoming articles, we will spotlight other phases of the project.