Regulatory Compliance in Medical Device Software Development: Strategies for Navigating Complex Requirements

Abstract

This abstract provides an overview of the challenges associated with regulatory compliance in medical device software development and presents strategies for effectively navigating complex regulatory requirements. The regulatory framework for medical device software encompasses various regulations, standards, and guidelines, including those issued by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and international bodies like the International Organization for Standardization (ISO). Compliance with these requirements is essential for obtaining regulatory approval, ensuring product quality, and mitigating risks associated with non-compliance. To navigate the complex regulatory landscape, manufacturers must adopt a proactive approach to regulatory compliance, beginning with a thorough understanding of applicable regulations and standards. This involves conducting regulatory gap assessments, establishing regulatory strategies, and integrating regulatory considerations into the product development process from the outset.