Navigating the Complexities of Documentation Compliance for Medical Devices

Regulatory requirements for Medical and Invitro Diagnostics Device Manufacturers have become increasingly complex, especially with the European Database on Medical Devices (EUDAMED). Incomplete submissions and lack of cohesive structure of technical documentation are the most common reasons for market approval delays, according to Notified Bodies (As defined by the European Commission: An organization designated by an EU country to assess the conformity of certain products being placed on the market). This presentation will explore how a data-driven and componentized approach to content management ensures consistency across data and content, accelerates documentation creation and review, and assures compliancy of documentation submissions in relation to device registration.. .