ISO 13485 & EU MDR - Expert Advice Community

FDA

Our company is ISO 13485:2016  certified. We have a new customer who wants us to manufacture and pack hearing aid. As you know FDA doesn't require 510K for Hearing Aid, but the customer wants us to register with FDA. 

Without 510K what will be our company's responsibilities for the product if we decide to register with FDA.
Please advise.

Thank you for your help in advance

SOP for Control of Nonconforming Product/Proces

Seperation of the ISO13485/MDR toolkit.

I received mdr ISO13485 templates and would like to know how to seperate the folder structure between ISO13485 templates and MDR? I have multiple products and desire one QMS.

When is there a need to open and handle a complaint?

Hello,

first of all thank you, that you offer this service and even free of charge!

I have more or less a simple question:
Does a complaint only begin when a company receives a complaint from a customer ( oral, written or electronic) OR also when a customer reports a case to a service hotline, e.g. if the medical device is not working properly and the service team can fix the problem - but there might be a problem with the device in general that needs to be investigated?
In the latter case, the company itself would initiate the complaint, but I wonder if this is even necessary because it was not officially reported by a customer?

I hope if it is clearly to understand what I mean.. :)

All documents required by QMS for ISO13485

I would like to ask if the list of internal documents priced for 9.9 include list of all documents required by QMS for ISO13485:206?
I need only list including tittles, for study pourpose.

Matrix for Requirements against Process/Department

May I request the matrix for ISO13485:2016 Requirement against process/ department for Gloves Manufacturing (Non-Sterile Examination Gloves) is for the guide for Internal Audit.

MDR labelling

Is it mandatory under MDR that labels and instructions of use to be translated in the languages accepted by the Member States of the Union where the medical device is going to be used by a patient? ( Article 10, subparagraph 11)
Would a company be compliant under MDR if the label attached onto the medical device is only provided in English and has a list with the flags representing the EU countries for customer to refer to the applicable language in the IOUs?

Contamination/requirements for sterile medical device contamination intro vitro diagnostic device (IVD) (i.e. IVD)?