Medical Device Testing Requirements Analysis
With your input, our business analysts and software engineers will help you create an FDA-compliant Software Requirements Specification
In many cases, the Requirements phase is the most difficult stage of new product development. Progress is stymied as companies struggle to define the requirements for an innovative new product. MIT’s Sloane Management Review refers to the “fuzzy front end” as the “area of greatest weakness in new product innovation”.
Syncro Medical will apply its decades of product development experience to help you power through Requirements Analysis. To do so, we utilize an array of tools and approaches —
- Use Cases/ User Stories
- UX Prototyping
- Interaction with key stakeholders
We have found UX Prototyping to be an especially effective means of exposing hidden medical software requirements. Using prototypes to simulate product behavior, participants can interact with screens to better imagine how the product will actually be used, thereby being able to anticipate important, but less-evident requirements.
If you haven’t yet completed your medical software requirements, we can get started with whatever you have available, such as a concept drawing, or high-level product requirements. With your input, our business analysts and software engineers will help you create an FDA-compliant Software Requirements Specification. To ensure effective documentation and tracking, we’ll employ a requirement management tool appropriate to the complexity of your new product (options range from Doors, to Case Complete, to Word/Excel).
The end-result of this phase will be a well-documented specification that meets Medical Device Software Standards such as IEC 62304. Requirements will be clearly stated, testable, and will support traceability.