FEATURE  Medical Equipment & Devices


Verifying and validating AI-based medical devices


 R


egulatory requirements in the European Union and other major medical markets do not currently address the unique and complex characteristics of medical devices   This gap between advanced technologies


that are available now and existing regulations poses a myriad of challenges to medical device  By leveraging advanced algorithms and vast amounts of data generated through   can quickly adapt to new information and changing conditions, as well as optimise their  can lead to improved treatment outcomes for patients, resulting in reduced costs and substantial gains in the overall quality of 


  potential for improving the quality of healthcare, they also present some important  The greatest challenge comes from the singular    Traditionally, the assessment of the


safety of medical devices has been based   14971 provides medical device developers with  However, many algorithms and data models  are not “locked” but instead continuously learn and adapt their functionality in real-time to   product development process and a different   code, which can be evaluated line by line for   


largely dependent on an assessment of both the quality and quantity of data since these 


16 February 2022 Irish Manufacturing


 data quality can include hidden biases in the selection and collection of data, or errors in    of data, in which data sets either align too closely or not closely enough with the data  assessing the quantity of the data required to        models are generally based on a highly nested     basis or the appropriateness of the model’s process There are at present no harmonised


  most, current regulations in major jurisdictions     should strongly consider taking a more expansive approach in assessing the safety of 


address every aspect of the product planning and development process, and extend beyond the initial product release date to include  To assist developers and manufacturers in


   “Requirements Checklist” for assessing the      


approach that considers all of the relevant processes and phases of the product   a comprehensive assessment of the risks  technologies throughout the entire product 





where a manufacturer outsources key    Until appropriate standards and regulations can be developed and implemented, the   


  www.irish-manufacturing.com


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