(Camstar: Charlotte, NC) -- Medical device companies are operating in a challenging environment of continuously innovating and launching new products while reducing product and process variability and risk and simultaneously complying with stringent Food and Drug Administration (FDA) regulations. Based on public data, there is a strong correlation that as a medical device manufacturer’s revenue increases through product and process innovation, their rate of adverse quality events such as product recalls, medical device reports (MDR), etc. also increases. Many companies have made heavy investments in a traditional quality system, and have seen little to no improvement in addressing these challenges.

But not all medical device companies are experiencing this, as some proactive companies have take action to balance these competing challenges and reverse this disturbing adverse quality event trend. How are they achieving this? Through electronic device history records (eDHR).

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