Medical Devices
A certificate of compliance with ISO-13485 (Medical Devices – Quality Management Systems – Requirements... View more
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The DIOM – A Powerful Tool for Compliance at Medical Device Companies
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The DIOM – A Powerful Tool for Compliance at Medical Device Companies
A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.
What is DIOM in Medical Devices?
A DIOM, or Design Input Output Matrix, is a very common tool used by medical device companies to show compliance to FDA 21 CFR Part 820.30, Design Controls, as well as ISO 13485:2016, Section 7.3, Design and Development.
Design inputs, outputs, verification and validation all work in partnership to ensure that the device meets user needs. Design inputs are the physical and performance requirements of a device which address the device’s intended use.
Design outputs are the result of the design effort, allow for evaluation of conformance to design inputs, and include acceptance criteria. Finally, design verification and validation, among other design activities and documentation, confirm that the design output meets the design input requirements. A DIOM shows compliance to this requirement within one easy-to-read, allowing for smooth-running design development projects.
A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. A simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.
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