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    ISO-13485-blog

    All posts by: Waqas Imam

    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...
    How to manage design and development of medical devices according to ISO 13485:2016
    The design and development process for medical devices is not as simple as in other manufacturing or service industries. Design...
    The design and development process for medical devices is not as simple as in other manufacturing or service industries. Design and development for medical devices has to deal with relevant regulations, product safety, and risk...
    Managing cleanliness of a product and contamination control according to ISO 13485:2016
    Most medical devices interact with the human body during the surgical process; just imagine if we didn’t have a cleaning...
    Most medical devices interact with the human body during the surgical process; just imagine if we didn’t have a cleaning process or sterilization process in place. Then, all of those medical devices would transfer physical...
    How to use ISO 13485:2016 to manage implantable medical devices
    A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended...
    A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended to stay in a human body for an extended period of time. Devices that interact...