Towards Computer Assisted Compliance Assessment in the Development of Software as a Medical Device
Authors
Sadra Farshid, Bruno Lima and João Pascoal Faria
Abstract
Medical devices (MDs) and Software as a Medical Device (SaMD) are essential for e-Health applications, but they must comply with strict standards and regulations to ensure their safety and effectiveness. However, there is a lack of tools to assist in conducting appraisals for compliance assessment and managing appraisal information. In this paper, after reviewing the most relevant standards and regulations for MD and SaMD cer- tification, we propose a web platform to help technology companies that lack expertise in developing SaMD to create compliant and high-quality products for the e-Health market. The platform provides users with custom checklists or questionnaires depending on the selected regulations, standards, risk classes, and product pa- rameters. Supporting a secure, incremental, and collaborative approach to completing the assessment process, the platform enables the attachment of notes, evidence, and improvement suggestions. It facilitates repeated assessments over time for data reuse and comparative analysis, enhancing the assessment process’s efficiency and effectiveness.