ISO 13485 & EU MDR - Expert Advice Community

Home / ISO 13485 & EU MDR

Discussions

Top Contributors

Expert

Rhand Leal

4148
Discussions
Expert

Carlos Pereira da Cruz

1915
Discussions
Expert

Dejan Kosutic

365
Discussions

Most Popular Tags

Product: Conformio Product: ISO 27001 Documentation Toolkit Product: ISO 13485 & MDR Integrated Documentation Toolkit ISO 27001 ISO 9001 Product: ISO 27001 & ISO 22301 Premium Documentation Toolkit Risk Assessment Product: ISO 13485 Documentation Toolkit ISMS register of requirements Internal Audit Product: ISO 27001/Risk Assessment Table Product: ISO 27001 & ISO 27017 & ISO 27018 Cloud Documentation Toolkit Certification ISO 14001
Select
CREATE NEW TOPIC +
Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • Managing ISO 9001 for Medical Device Distributors who are not manufacturers

    How to manage ISO 9001 for Medical Device Distributors who are not manufacturers.

  • Why would a non-medical dev manufacturer want to implement QMS using 13485?

    Hi, I’m looking for some guidance with quality manual and quality policy, can you help?
    ISO 13485 is for medical device manufacturers- why would a non-medical dev manufacturer want to implement QMS using 13485?

  • Class IIa product

    We are looking to expand our activity in *** as a gate to *** countries and the EU.
    Our solution is a support information system for physicians helping them in better identification and treatment of respiratory infectious diseases.
    We would like to know what it takes for ISO approval as part of the CE submission in time and money?

  • Following same model by the health authorities or by ISO standards

    We are an aligner/invisible braces manufacturing company having our head office in *** and manufacturing unit in ***. We would like to expand our business to *** and *** where we would like to sell our products directly to consumers as explained below:

    1- A patient will order impression kit and take his/her impression by his/herself and send it back to the company
    2-Company then prepares a treatment plan with the help of dentists and orthodontists and send the plan back to the patient for approval.
    3- After approval, company will manufacture aligners and send it to the patient.

    The whole process is monitored by dentists/orthodontists.

    The same model is being implemented in many countries worldwide, a few examples are ***, ***, ***, etc.

    Our question is that are we legally allowed to follow the same model in *** and *** by the health authorities or by ISO standards.

    Thank you!

  • Information on product and packaging labels

    The label information covers only UDI, but there is no information on product and packaging labels. The product label just does not contain UDI information, UDI is one element of the packaging label. What other information is mandatory for product and packaging label for e.g. the label will have manufacturer address, date of manufacturer, symbols including serial number, etc. I am expecting a procedure for labeling which also includes what information an user manual should have for both end-users and professional users etc.

  • Is 13485 Mandatory for making IR Thermometer?

    We are entering the market of medical devices - To start with IR Thermometer.
    1. Is 13485 Mandatory or ISO 9001 With the scope covering IR Thermometer enough?
    2. Is 13485 Certification mandatory to obtain the CE Mark?

  • Requirement of ISO 13485

    We are currently developing self-scanning application for a Thermal IR camera to help diagnose early-stage cancer as well as Pet care, with the help of AI.
    I have a basic question here regarding ISO 13485, whether we will require this standard for our application or Not?

    The concern has arisen as this application will give only indication/guidance to the user to go further to visit a doctor if there are any abnormalities/outliers using AI.

  • IS ISO 13485:2016 latest version?

    Would you say, ISO 13485:2016 is this latest version, isn't it? Exclusion clauses are 6,7,& 8?

  • ISO 13485 implementation

    1. The first thing I would do myself is to implement a general procedure to keep track of actions and agreements within the organization. I do not see it? Why? How to do it?

    2. We are a very small startup for a simple small noninvasive medical device. Both my partner and myself are very experienced in MRI (***), CT (***), etc, although it is 20 years since we worked in a QMS. I want to define Research and predevelopment as a process outside the QMS, then Design transfer to a clinical trial process and to subcontractors inside the QMS We will subcontract engineering/development, manufacturing, service, logistics to ISO13485 certified high-quality partners. We will have these partners audited regularly by consultants we contract and sign the audit reports ourselves after review. Can we somewhere buy a core (just enough) QMS that complies with ISO13485? Your toolkit is much more than we need, do you have a core toolkit as well?

    3. Do you have a service that adapts your toolkit to our needs? Including filling in of company name etc.

  • Affixing ISO 13485 mark on product

    If I am certified with ISO 13485. Is it applicable to put ISO 13485 mark or slogan on my medical device product? And what is the reference of your answer if it is yes or no?
Page 44 of 66 pages