ISO 13485 & EU MDR - Expert Advice Community

Home / ISO 13485 & EU MDR

Discussions

Top Contributors

Expert

Rhand Leal

4151
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 Product: ISO 27001 & ISO 22301 Premium Documentation Toolkit ISO 9001 Risk Assessment Product: ISO 13485 Documentation Toolkit ISMS Internal Audit register of requirements Product: ISO 27001 & ISO 27017 & ISO 27018 Cloud Documentation Toolkit Product: ISO 27001/Risk Assessment Table ISO 9001:2015 ISO27001
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

  • 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?

  • ISO 13485 Documentation & implementation

    I want to ask that ,is ISO all documentation is same for disposable medical device & IVD or any change in IVD ?

  • IVD Medical Devices for Infectious Diseases

    1. For IVD Medical Devices for Infectious Diseases e.g. Covid-19 are these classified in IVDR as high-risk Class D?

    2. And must the CE Mark have the NB 4 digit Number next to the CE Mark?

  • Cross-mapping ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards

    I am trying to cross map ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards that apply to medical testing labs that develop IVTs. In development of a QMS that will satisfy all of them. Any advice?

  • UDI procedure that covers the EU MDR requerment

    Hi Do you have UDI procedure which covers the EU MDR requerment. 

  • Is special training necessary to get company certified to ISO 13485?

    We are ISO 9001 certified company. I'm lead auditor certified. Do I need to take special training to get the company certified to ISO 13485?

  • Guidelines for getting a record retention policy

    I have a query ... if we are maintaining a record book at laboratory level on medical device experiments what guidelines we should follow in order to get a record retention policy.
Page 45 of 66 pages