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Product complaints
Is there a deadline for handling product complaints?
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Mould validation
How important is the mould validation documents?
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Conformance with ISO 13485
Does 21 CFR 820 requires conformance with ISO 13485?
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First qualified person
Qualification procedures need to be developed and implemented for a test or a certain manufacturing procedure. A test, OJT or validation should be included. However, who can be the "first" qualified person? For the validation of the qualification, there needs to be a person to compare. We are in the process of first developing the qualification procedure. Do we need to establish a procedure that specifies the first person to be qualified? Or can anyone or someone who had been doing the job become a first qualified person?
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Complaint handling and vigilance reporting
Pl. enlighten me on the following: How and where to include the determination of vigilance reporting in the customer complaint procedure or process -
Transition to ISO 13485:2016
We have an assessment of our QMS to 13485-2003 and need to be in line with 13485-2016 what is the best way to accomplish this?
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Effectiveness of QMS and Product Recall
1. How can you measure the effectiveness of QMS? 2. Do every product recall will require an advisory notice? Is there any advisory notice which will not required a product recall? -
Customer feedback
Our product is a class III single-use sterile device. We don't have any customer property and therefore Customer property, Installation, and Service have been excluded (not applicable). Does customer complaint/ feedback consider as Customer property?
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Medical Device File
I just start to work on document and record control. I cannot find "Medical Device File" in the tool kit. Could you provide me some guidelines/examples?
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Quality management
Does any ISO 9001, 13485, etc require a company to have a Quality manager? I know ISO 17025 and ISO 34 did.