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Minimum Information Required for Medical Device Complaint Investigation

What is the bare minimum information required for a medical device complaint investigation? In my experience, I recommend the following is captured at a minimum: Name of the device Date complaint received Any device ID (e.g. part #, lot or batch #) Complainant contact information Nature and details of complaint Dates and results of investigation […]

Medical Device Design Control Greenlight

What do you think of when you hear the term “green light”? I hear “go”! In the medical device world, getting the “green light” can mean a lot of things–all positive. Getting the green light from FDA means your submission is cleared, and you can go to market. But as medical device product developers, we […]