By defining requirements in Tento+, you will build a product specification that is compliant with all major design standards. Your product specification is really the back-bone of your design control process and is commonly the starting point of Tento+ users. Without clear requirements, it is difficult to document test plans and design traceability.
Requirements in Tento+ are divided into three types:
- Product Level/User Needs: At the highest level, product-level or user needs to represent the overarching objectives and goals of the product. These requirements are typically derived from use specification, market research, clinical input and stakeholder expectations.
- System Level Requirements: System-level requirements bridge the gap between user needs and the technical implementation of the product. These requirements outline, at a system-wide level, the functionalities, features, and performance criteria that the system must adhere to. They serve as a roadmap for system architects and engineers.
- Component Level Requirements: Component-level requirements delve into the specifics of each subsystem or component within the system. These requirements break down system-level functionalities into more granular requirements, detailing how each component should behave and interact with others.
You’ll need requirements for each of the above types, and moreover, we find it easier to manage groups requirements within each type in.
Requirement groups organise our requirements into manageable sections, and are often grouping similar requirements. For example, the group “Labelling and Documentation” could define the requirements for the accompanying literature and any labels you have to apply to the device.
Making a requirement is super easy, just select Create Group within the requirements type. When you create a group, you’ll be asked which of the three types above does this requirement represent. This is important for showing a heir achy of requirements required by all major standards.
Individual requirements can then be placed under requirement groups heading from within the table. Simply press +Add and a new requirement will be added ready for you to populate.
Here we can add a requirement title/description, give it a reference number, provide further acceptance criteria or measurable details. You can also link requirements to tests (if you have written your test plan already) straight from the requirements table. The status of the requirement will update automatically depending on the status of the associated tests.