Feedback is about being proactive, whereas a complaint is typically reactive in nature.

Feedback is about soliciting information to confirm that customer requirements have been addressed. Define procedures for gathering this feedback. And I encourage you to do so for all customer types for your products. Realize that the feedback you get may be positive, negative, or neutral.

The information you gather will be helpful too with post-production risk management.

Remember, risk management is a total product lifecycle process. And the information you learn post-launch will be helpful in ensuring your risk assessment, evaluation, and controls were properly captured.

Complaint definition:

A complaint is written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices. 

 When you identify a complaint, there are certain minimum requirements that should be documented. You need to have a complaint handling procedure to define these requirements and process.

Complaint records need to capture:

  • Product information, including product name, lot number, UDI, and any other identification information.
  • Details of the issue, including date of the event.
  • Date complaint received.
  • Date and results of investigation.
  • Any corrections and/or corrective actions taken.
  • Correspondence with the person making the complaint.

Complaints generally have higher focus and visibility with regulatory agencies, especially during audits and inspections. With complaints, you need to assess whether or not further corrective action is required. As with feedback, complaints need to be part of your product risk management process.

Note that when you solicit proactive customer feedback, you may uncover an issue that needs to be logged as a complaint. If so, be sure to follow the complaint procedure for doing so.

Also realize that with both feedback and complaints, there are some events that might require further investigation and notification of regulatory authorities.

Generally speaking, these adverse events contributed to, or could have contributed to, serious injury or death. Hopefully you never encounter these types of situations. Regardless, you need to have established procedures that address how and what to do, if you receive adverse events.

Yes, I want you to take feedback and complaint processes seriously and realize how beneficial these post-market activities can be in analysis and improvement of your medical devices.

Please, please also take adverse event reporting very seriously. 

Number one reason: this means there was some type of situation where a patient or end-user got injured. Secondly: you have a limited amount of time to react and respond to these events with regulatory agencies. So become very familiar with the specific regulatory requirements for the markets you are in with your products.

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