In the general flowchart of the ISO standard, the customer is always at the final stage: that means that the organization exists to serve its customers. The organization is required to constantly assess whether it has achieved the customer's requirements. While the ISO 9001 Standard give large scale to customers' satisfaction, the ISO 13485  Standard  does not consider customer's satisfaction as much as customer's feedback about the medical device:

• Does the medical device compete with the customer's requirements
• Does the medical device compete with the regulatory requirements

The reason for the difference is that satisfaction is a subjective matter where achieving customers or regulatory requirements are objective matters that could be assessed and measured. A customers' satisfaction survey may turned out to be diverted and therefore would provide an inaccurate results. The medical device shall first apply to the regulatory and customers requirements. The measurement of the feedback is to be conducted on a continuous manner in order to maintain effectiveness. Sounds familiar? You bet. I had already mentioned it tens of times on this web site.

 How one can measure feedback? It's a good question.

• Customer's Complaints – the organization must monitor customer's complaints regarding the medical device. The complaints shall be gathered by the distributor of the medical device and he shall report to the manufacturer. The organization shall focus on complaints that relate to the functionality, characteristics and performances of the medical device. In other words, the organization is not required to refer to complaints such as "the medical device color does not match our operation room. Is there any chance you can color it blue? We would appreciate it…" The organization is required to maintain a documented procedure to ensure that every complaint would:

• documented
• be handled in a defined time frame
• be evaluated to determine whether the complaint represents a risk to the medical device and a failure to achieve the requirements.

• User surveys – the manufacturer may conduct surveys relating to relate to the functionality, characteristics and performances of the medical device.

• Reviews – the manufacture may order or initiate a review regarding his medical device. The purpose is to examine through objective point of view the functionality, characteristics and performances of the medical device.
• Journal reviews – it may not be the most reliable source of information, but in some cases under the right circumstances it may shed the right light about some tendencies. 
• Periodic post production preview phase – usually relates to the risk analysis stage while designing a product. Any quality problem, that may affect the medical device from achieving the requirements, is detected during the risk analysis phase. must be submitted.

Next requirement is to submit any non conformity that was detected during the assessment of customers' feedback to a corrective or preventive action. The feedback shall provide an early warning for quality problems. In other words, the feedback outputs are to be defined as one of the corrective and preventive action's inputs. Corrective action would regard as a non conformity detection and preventive action as an early warning.  

Documentation Documentation Documentation
As (almost) always, the ISO 13485 Standard requires documentation. Otherwise how may you prove implementation? First level of documentation is a documented procedure to describe the method. The organization is required to document as well the authorities and responsible parties that shall attend the feedback method.
Second level are records of the feedback activities such as documented complaints, surveys etc. Each of the records shall bare a decision accepted as a result for the data analysis and a reaction plan. The reaction plan may be defined as corrective or preventive actions or a continual improvement.