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  • 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?


    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.

  • Medical device classification

    Now we registering a new product, indicated to aid in weight management in overweight and obese adults(inside each capsule the two ingredients form a three-dimensional hydrogel matrix. once in the stomach, the capsules break apart, exposing the matrix to water. each of hydrogel cells can absorb up to 100 times its weight, growing in size to occupy space in the stomach)
    our marketing authorization asks for ISO 13485 and CE but after reviewing the scope of iso 13485 and the MDR, I can't classify this product under any rule.
    kindly advise, is this product consider a medical device?

  • 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?

  • SOPs ISO 13485 General

    For a medical device in the pre-market stage, that is, in the final stages of design and development, we have recently started the QMS process. What are ways in which we can go back and document changes made in the design and development of the device? Going forward we will start a formal ECO process but for any changes that have occurred, we have been compiled a list but do we need to show how each change was assessed? Do we need to follow a formal process although this did not exist when changes were being made? How do we determine which changes need to be in the list? For example, we have thousands of software changes, do we document all?
    This has been a bit difficult to navigate as the device is not yet licensed and it still under design and development.
    Thank you immensely for any advice you can give.

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

    I seeing in the 13485 requirements. would this requirement be applicable to IVD ? Currently we we are not sterilizing anything? Could you please provide a list of items that would require sterilizing in the process/lab per the clauses listed in the standard below? Arrangements for the control of contaminated or potentially contaminated product 6.4.2
    Requirements for control of sterile medical device contamination 6.4.2
    Thank you in advice. I am confused and need confirmation/clarity.

  • What in ISO 14534: 2015 should be applied to contact lens care products?

    I am interested in the following:

    What is it in ISO 14534: 2015 that should be applied to contact lens care products and not found in 
    93/42 /EEC?

  • Performing validation of process/activity

    How to perform a validation of the process/activity?

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