User Feedback both negative and positive and acting upon those metrics

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#1
A requirement for FDA and 13485 is user feedback both negative and positive and acting upon those metrics.

Our product once was sold primarily in retail so we used feedback from Amazon and Walgreens etc from the web and social media

Our new product is consumable in the hospital. My fear presented to management is that nurses will simply throw away a device that isn't working and we won't be able to capture the detail we did in the retail space. Is a survey acceptable in this case?
 
#3
I am no expert in 13485, but is seems as long as you have a mechanism to solicit feedback I would hope you're good. You can't make people use it. One of my customers makes a disposable product. Most "issues" are literally thrown away as it's not worth the effort.
 

Ronen E

Just a person
Staff member
Super Moderator
#4
1. "Feedback" also includes positive responses, don't over-focus on "issues".
2. For low-cost disposables we use to have a rule-of-thumb saying that the ratio of notified to non-notified events is 1:10.
 

somashekar

Staff member
Super Moderator
#5
A requirement for FDA and 13485 is user feedback both negative and positive and acting upon those metrics.

Our product once was sold primarily in retail so we used feedback from Amazon and Walgreens etc from the web and social media

Our new product is consumable in the hospital. My fear presented to management is that nurses will simply throw away a device that isn't working and we won't be able to capture the detail we did in the retail space. Is a survey acceptable in this case?
Hi.. You can decide the method(s) for obtaining the feedback, and document the same. You are OK if any one or more of the methods you have adopted is working for you.
The purpose of gathering the feedback are two., per the ISO 13485.
Measurement of the Effectiveness of the Quality management system
Monitoring and maintaining of the Requirement of the product
The areas from where you need to gather feedback are two., per the ISO 13485
Production activities
Post-Production activities
Therefore if a survey is effectively planned and made to be capable to give you such a feedback....why not.
You must be able to get such feedback so as to take it into your device risk management as well as to QMS improvement process.
Feedback is therefore always two fold and from two areas.
 

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