Your Marketing team member has determined there is a need in the market for a new product for your company. He/She has completed a pretty thorough exercise of collecting User Needs through site visits and focus groups and has documented this in a Marketing Specification document (not version controlled), using a template the Marketing team has developed. Summary of their product overview: A point-of-care diagnostic instrument to test for the COVID-19 virus, which can be used by field medical personal to test for the appearance of virus antibodies present in the patient. It must be highly reliable and produce test results quickly. The R&D team is highly motivated to begin and have already started designing a prototype system, using an existing diagnostic test system the company already sells for other antibody testing- preliminary data collected in a study and documented in a lab notebook demonstrates the system can detect the antibody. Based on these results, R&D has started building the Design History File and has scheduled a formal Design Review with cross functional team members. They are recommending using the Marketing Specification and lab notebook data to draft the official testing summary report for the potential FDA submission. Are they ready? Why or why not? explain with references.

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