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    ISO-13485-blog

    Tag: “ISO 13485”

    Production and service provision process in ISO 13485
    Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The...
    Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The main reason for this is the fact that the standard aims to define requirements applicable...
    How to define roles and responsibilities within an ISO 13485-based QMS
    When you are developing a Quality Management System (QMS) it is necessary to assign and document the roles and responsibilities...
    When you are developing a Quality Management System (QMS) it is necessary to assign and document the roles and responsibilities of your management system. ISO 13485 highlights this as shown primarily in the requirements of...
    How to perform management review according to ISO 13485
    Many companies see Management Review as an unpleasant necessity for maintaining compliance with ISO 13485. If used properly, however, this...
    Many companies see Management Review as an unpleasant necessity for maintaining compliance with ISO 13485. If used properly, however, this is far from the truth. Regardless of how you organize your management review, either through...
    What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices?
    Today’s business owners have a wide array of concerns, not the least of which is turning a profit in what...
    Today’s business owners have a wide array of concerns, not the least of which is turning a profit in what can be a volatile economy. However, financial success is of little consequence if the government...
    How to use ISO 13485 to comply with In Vitro Diagnostic medical devices (IVD) requirements in UK
    In vitro literally refers to a test or examination outside a living organism. This happens in a laboratory or a...
    In vitro literally refers to a test or examination outside a living organism. This happens in a laboratory or a vessel or any other controlled testing location. In vitro diagnostic medical devices (IVD’s) comprise of...
    Medicines and Healthcare products Regulatory Agency in the UK – What does it do and how can ISO 13485 help?
    The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s governmental agency that controls and regulates blood components...
    The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s governmental agency that controls and regulates blood components for transfusions, advanced therapy medical products, medicines and medical devices throughout the United Kingdom. MHRA...