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Medical device manufacturers can undertake continuous improvements by changing the design of the existing medical device or by developing a new one. This can be done by putting a strong complaint handling process in place for customer or end-user satisfaction. Once the medical device is launched in the market, the performance can be judged by seeking feedback and from the complaints received from the end user.

This whitepaper gives brief description on how to extract the medical device complaints from FDA - MAUDE data base and analysis of extracted and internal complaints for:

  • Post Market Surveillance (PMS) activity wherein the medical device manufacturer can analyze the issues with the medical device and update the design, process based on risk analysis performed.
  • Design a new product to overcome the flaws or drawbacks of existing products.

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