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

  • 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.

  • Inlininig procedure for CAPA

    What action we need to do to inline our procedure for CAPA for below requirement & how to be covered in CAPA report
    "planning and documenting action needed and implementing such action, including, as appropriate, updating documentation"

  • Software as Medical Device

    We are a product development company in the Netherlands in Infrared thermography, and we would like to know how and if Software as a Medical Device and respected certification applied to our company? 

  • Implementing 13485 as a wire harness supplier

    Hi, We are supplying wire harness to automotive industries and planning to implement TS 16949. We believe there might be a requirement from our client to be 13485 certified. So I am thinking of preparing both at the same time to safe time.

    1. Does it make sense for us to implement 13485 as a wire harness supplier?

    2. If so, does it make sense to prepare both satndards at the same time?

  • Addressing Procedure pack in the ISO 13485 Manual

    How can I address the Procedure pack in the ISO 13485 Manual?
Page 46 of 67 pages