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Questions and Answers
What is the main purpose of ISO 13485 standard?
What is the main purpose of ISO 13485 standard?
Which organization publishes the ISO 13485 standard?
Which organization publishes the ISO 13485 standard?
What type of companies does ISO 13485 specifically apply to?
What type of companies does ISO 13485 specifically apply to?
What is a key benefit of complying with ISO 13485 standard for medical device manufacturers?
What is a key benefit of complying with ISO 13485 standard for medical device manufacturers?
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What does a company need to demonstrate to achieve certification under ISO 13485?
What does a company need to demonstrate to achieve certification under ISO 13485?
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Which area is covered by controls under ISO 13485 standard?
Which area is covered by controls under ISO 13485 standard?
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What aspect of production does ISO 13485 focus on?
What aspect of production does ISO 13485 focus on?
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Which of the following is NOT a requirement set forth by ISO 13485 standard?
Which of the following is NOT a requirement set forth by ISO 13485 standard?
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'Achieving registration indicates that a firm's products comply with the requirement set forth by regulators' - This statement refers to which benefit of ISO 13485?
'Achieving registration indicates that a firm's products comply with the requirement set forth by regulators' - This statement refers to which benefit of ISO 13485?
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Study Notes
ISO 13485 is one of several standards published by the International Organization for Standardization (ISO) which provides specific requirements for quality management systems within organizations involved with medical device design and manufacturing. It was first introduced in 1996 and has since been updated multiple times, most recently being revised in October 2016. This standard applies specifically to manufacturers of active implantable and non-implantable medical devices and related accessories.
The purpose of this standard is to ensure that companies meeting these criteria have a well-developed quality management system that focuses on ensuring patient safety and product reliability. It helps monitor compliance with other relevant regulatory requirements such as those imposed by the Food & Drug Administration (FDA). Compliance with this standard simplifies conformity assessments because it demonstrates stringent controls over procedures throughout all stages of production.
To achieve certification under ISO 13485, a company must demonstrate effective control of processes and services from initial concept through delivery. These controls cover areas including risk analysis, traceability, document handling, and change management among others. Achieving registration indicates that a firm's products comply with the requirement set forth by regulators concerned with patients’ health, thus making them safer for consumers worldwide.
In summary, ISO 13485 specifies the necessary administrative steps to obtain a certified quality management system suited for medical device manufacturing. By implementing and maintaining a process focused on quality, firms can increase their credibility while simultaneously improving efficiency and reducing costs associated with defective goods.
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Description
Learn about the ISO 13485 standard, which outlines requirements for quality management systems in organizations involved in medical device design and manufacturing. Discover how compliance with this standard ensures patient safety, product reliability, and regulatory compliance.
