We are working within a design control framework, which is used in biomedical engineering and medical device development. It ensures that our device will be safe, effective, and compliant, and that it is what customers really need. The key stages we are following are
- Defining the problem: Ensuring that we clearly define the problem we are solving, who the product is for, and how it will be used
- Design Inputs: Defining the requirements, specifications, and justifications of the device
- Design Outputs: Generating tangible values and recordings for the user
- Design Verification: Confirming the design outputs meet the design inputs
- Design Validation: Ensuring the final device meets user needs
- Risk Analysis and Safety: Identifying potential hazards and ensuring the safety of the device for the user
- Design Review: Performing regular checks to ensure the design process is following the proper standards and is staying on track
This framework allows us to ensure that OvuTrack will be functional, reliable, usable, and truly relevant for its users seeking to better track fertility solution