{"id":24993,"date":"2023-10-23T05:00:00","date_gmt":"2023-10-23T03:00:00","guid":{"rendered":"https:\/\/sii.pl\/blog\/?p=24993&category=hard-development"},"modified":"2023-10-23T11:32:52","modified_gmt":"2023-10-23T09:32:52","slug":"the-importance-of-traceability-from-the-perspective-of-designing-a-medical-device-software","status":"publish","type":"post","link":"https:\/\/sii.pl\/blog\/en\/the-importance-of-traceability-from-the-perspective-of-designing-a-medical-device-software\/","title":{"rendered":"The importance of traceability from the perspective of designing a medical device software"},"content":{"rendered":"\n

When designing a new product for the regulated environment, each manufacturer meets the challenge to provide compliance with multiple standards and regulations to achieve the certification required to release a product on the market. Therefore, he needs to ensure notified body that the device is safe and works as intended. Experience suggests that well-prepared documentation<\/strong> during the design process is a key factor in achieving this goal.<\/p>\n\n\n\n

In the process of designing the product, some documentation path that leads from input parameters to specific design decisions at each sub-stage should be created. This kind of process is nothing more like the basis for maintaining product traceability.<\/p>\n\n\n\n

When learning about any design process, you may hear about traceability and its importance in Quality Management System (QMS). This article describes the use of this term in one of the most regulated environments – medical device software design.<\/p>\n\n\n\n

Traceability in general<\/strong><\/h2>\n\n\n\n

There are plenty of definitions of traceability in literature. The one that accurately captures its meaning is:<\/p>\n\n\n\n

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<\/p>\nRequirements traceability refers to the ability to describe and follow the life of a requirement, in both a forwards and backwards direction (i.e., from its origins through its development and specification to its subsequent deployment and use, and through all periods of on-going refinement and iteration in any of these phases)<\/em> [1]<\/a><\/strong><\/em>
<\/cite><\/blockquote>\n\n\n\n

In other words, in the term \u2018Traceability\u2019 two simple words are hidden \u2013 \u201ctrace\u201d and \u201cability\u201d. This combination may mean the product’s ability to trace the history of the requirements specified for that product.<\/strong><\/p>\n\n\n\n

Traceability in the medical device domain<\/strong><\/strong><\/h2>\n\n\n\n

The main standard that specifically addresses the requirements for the traceability of medical devices is ISO 13485. In the product realization chapter, the following can be found:<\/p>\n\n\n\n

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<\/p>\nThe organization shall document procedures for traceability. These procedures shall define the extent of traceability in accordance with applicable regulatory requirements and the records to be maintained<\/em> [<\/strong><\/a>2<\/a><\/strong>]<\/strong><\/a><\/em><\/cite><\/blockquote>\n\n\n\n

Traceability shall accompany the main stages of medical device realization, especially including the product implementation plan or design and development plan. However, it is worth mentioning that ISO 13485 does not describe the specific methods or technologies to be used, but defines general requirements for traceability. The way a medical device is tracked may vary depending on many factors, like the type of device, intended use, or regulatory jurisdiction.<\/p>\n\n\n\n

Standards, guidelines, and regulations<\/strong><\/h3>\n\n\n\n

In addition to ISO 13485, other standards, guidelines, and regulations, for example: <\/a><\/p>\n\n\n\n