The first issue is the context of your question. You start with the context of a class 1 medical device in the EN ISO 13485 environment, but then shift to the definition from FDA.
I infer the context is EN ISO 13485:2012. The definition of a complaint and the requirements to handle complaints are not the same in FDA QSR and in ISO 13485:2012. You say this is a class 1 device, but you don’t say where. The devices classes are not the same in the US, the EU, or Canada.
Because you raised an EN ISO 13485 environment, I’ll infer the question concerns the EU. Presumably, you apply the CE Mark without a Notified Body.
A customer complaint, in EN ISO 13485:2012, is an allegation of a deficiency related to at least one of the enumerated characteristics. The first question is whether the customer complaint concerns one of those characteristics. For example, an allegation of a late delivery would not qualify as a customer complaint. In your case, if a customer alleges the device should do “X” but doesn’t, the characteristic is probably performance. Unfortunately, neither EN ISO 13485:2012 nor ISO 9000:2005 defines performance.
In Clause 7.3.2.a design inputs include “functional, performance and safety requirements, according to the intended use”.
A simple classification would determine if the communication concerns required performance that is deficient. Required performance could come from the MDD Annex I, some standard you followed (in your technical documentation), customary requirements for this type of device, or some characteristic that your company decided to include. If the communication is not of this flavor, then it is not a customer complaint.
If it were a customer complaint, then Clause 8.5.1 would require records of investigation and either corrective action, preventive action, or a record of why neither was conducted. In other words, there is an assumption that the complaint is a nonconformance.
I would recommend that your company track feature requests because they provide useful information for product updates. EN ISO 13485:2012 takes the position that customer satisfaction is not an appropriate regulatory objective of medical devices. However, your company’s long term viability may depend on effective collection and use of this information.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 02-05-2016 11:27
From: Jim Watkins
Subject: Complaints vs Feature Requests
Greetings to all.
I would like some guidance/suggestions on handling customer feedback on a class 1 medical device in the EN ISO 13485 environment. Specifically relating to Complaints and requests for features not in the device.
Background: In 21 CFR 820.3(b) a Complaint is defined as:
- Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution
.I was not able to find any reference to feature requests other than as input to design. :
Some large companies log all customer interactions (complaints, feature requests etc) into a database and then that data can be analyzed for trends, feeding into CAPA or VOC for the next product upgrade.
Smaller companies tend to use spreadsheets for entering/tracking complaints, but other customer interactions may not be documented.
My questions are:
- If a customer ‘alleges’ that my device should do ‘X’ but ‘X’ is not a feature in the device, is it a complaint or feature request?
- If we get a lot of feedback about the device not doing ‘X’, at what point, if ever, does it become a complaint?
- What is best practice for differentiating between feature requests and complaints? Is there a guidance document I missed?
Comments and suggestions invited.
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Jim Watkins
DIrector of Quality
Lebanon PA
United States
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