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Write Procedures You Will Use

Over the past several years, we have done a great deal of work helping companies with medical device quality system procedures. I pretty much have 21 CFR 820 and ISO 13485 memorized. If you ask us to author a FDA / ISO compliant quality system, we can do this. Our objective is simple. We want […]

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 […]