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    ISO-13485-blog

    Tag: “medical devices”

    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...
    Considering human factors in Medical Device Design
    Human factors are one of the most important considerations in the design of medical devices, and are reflected in an ISO...
    Human factors are one of the most important considerations in the design of medical devices, and are reflected in an ISO 13485 Quality Management System as design and development inputs. Human factors to consider include the requirements...
    How to use ISO 14971 to manage risks for medical devices
    A patient undergoing a surgical procedure places his trust in the surgeon, the institution, and the procedure of surgery. He...
    A patient undergoing a surgical procedure places his trust in the surgeon, the institution, and the procedure of surgery. He is least concerned about the medical devices, and not aware of the associated safety risks....
    How to use ISO 13485 to fulfill FDA regulatory classes for medical devices
    As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable...
    As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. Compliance with regulatory requirements is given equal importance in...
    Using ISO 13485 to manage process validation in the medical device manufacturing industry
    During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods...
    During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods stage. Industrial processes in medical device manufacturing facilities convert raw materials into semi-finished materials, and...
    How to manage recalls and advisory notices for medical devices according to ISO 13485
    A recall, along with necessary advisory notices, is an important but reactive approach that is used by medical device manufacturers...
    A recall, along with necessary advisory notices, is an important but reactive approach that is used by medical device manufacturers to remove a medical device from the market due to regulatory violation, serious risk of...