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    ISO-13485-blog

    Tag: “ISO 13485”

    Calibration requirements in ISO 13485
    Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485 mean high precision and close...
    Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485 mean high precision and close monitoring. The manufacture of medical devices makes use of various types of equipment and measuring...
    Design and development validation and verification according to ISO 13485
    Producing any part of a product includes validation and verification in its design and development. ISO 13485 requirements are a...
    Producing any part of a product includes validation and verification in its design and development. ISO 13485 requirements are a great way to start, since it’s targeted specifically to medical device manufacturing. According to the...
    How to comply with section 8.2 Monitoring and measurement in ISO 13485:2018
    Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management...
    Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have met the expectations in...
    How to comply with the latest changes in ISO 13485 clause 7.2.3 Communication
    Communication is considered to be one of the crucial factors in compliance with ISO 13485. Poor communication practices, such as...
    Communication is considered to be one of the crucial factors in compliance with ISO 13485. Poor communication practices, such as relying on verbal agreements and failing to document changes, could lead to high costs in...
    How can ISO 13485 clause 7.4, Purchasing, enhance procurement?
    We often cover four basic elements in sourcing a product for the company. These include the nature of the purchase,...
    We often cover four basic elements in sourcing a product for the company. These include the nature of the purchase, the cost of the product, the quality of the product, and previous purchasing experience. This...
    Common mistakes with ISO 13485:2016 documentation control and how to avoid them
    Documentation control is the first task that most people would prepare for before an upcoming audit. Prior to an audit,...
    Documentation control is the first task that most people would prepare for before an upcoming audit. Prior to an audit, we would ensure that any changes made to the work procedures are updated, review the...