Customer Feedback Medical Devices

#1
Hello Everyone,
I am working in a start-up developing an innovative product. The development of the product is still on the clinical phase, therefore, for the moment we have no clients. Yet, during the last audit, the auditor has asked us to implement a customer feedback processus. Please do you have any idea of how can we manage a customer feedback during the clinical phase? Thank you in advance for your return
 
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#2
You need a feedback process, not a customer feedback process. What do you do currently when a clinical product has an issue? If there is a nonconformity, you should open up a nonconforming product report. If corrective action is required, a CAPA. Information from these should be feed into the risk management process. How do you document clinical adverse events? How is this information fed back into risk management and improvement processes?
 
#3
Hello Everyone,
I am working in a start-up developing an innovative product. The development of the product is still on the clinical phase, therefore, for the moment we have no clients. Yet, during the last audit, the auditor has asked us to implement a customer feedback processus. Please do you have any idea of how can we manage a customer feedback during the clinical phase? Thank you in advance for your return
Hi ERRABIE...
Please note that the requirement is Feedback per Clause 8.2.1 and one of the requirement within is about gathering data from post-production activities.
You will be therefore having a documented procedure for this feedback process that will address both data from production as well as post-production (customer feedback)
You may not have any data from customer feedback, but the method to gather and monitor information from customer has to be documented and be ready to use at the appropriate time.
 
#4
Hi. Always difficult at the beginning and any decent auditor will understand that. Key is to have a process and have a plan. Other posts are correct. Requirement is to define the feedback loop, and that’s not just customers. Think about where you will obtain data, what you will do with it, the triggers/KPI/targets set for that data and what you do after your analysis is complete (CAPA, design changes etc). Collect as much data as you can and don’t forget the “internal” data. Pull it all together and explain what you are doing, why and how you intend to develop the system going forward as you collect more data. A good system should embrace continuous improvement and be shaped somewhat by the data. Good luck.
 

Junn1992

Quite Involved in Discussions
#5
recommend to start thinking about the survey forms you will use post market to gather information about your product in the field. good to use a simple form that is easy to fill out, digital solutions recommended. Once you know what questions you want to ask, what data you want to collect, then the "review and processing" during management review ISO 13485 clause 5.6 becomes easy
 
#6
Hi

I would like to ask a follow up question

I work for a Medical device CEM and we serve customers from start-ups to large estabished organisations. With the start-ups, we see a significant number of design changes to their prodcuts throughout the NPD/NPI cycle and although we similar types of changes with arge estabished organisations, the frequency of change is lot less.

Im trying to understand why this, do they have a different operating model, rushing there product to market with carryinng out the intial concept and feasbility phases etc. Any feedback or comments would be appreciated
 
#7
Startup companies have new products that they themselves are learning about. As they learn, they must change their product to meet the customer's needs and to improve the product's safety. Established companies usually base new products on existing products they have a lot of knowledge of. They don't have to learn as much because they already have the knowledge. This means less changes to the product. Also, yes, startups need to move fast, and they often make mistakes along the way that need to be fixed. Established companies are less worried about money, and so they can take more time to be methodical.
 
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