Technical documentation management is a dynamic process throughout the product lifecycle, encompassing design, development, and post-market activities. It serves as a centralized repository for product information from multiple departments, including research, development, marketing, production, regulations, and quality control.
Current challenges in technical documentation management include manual handling, which involves paper-based processes, leading to the risk of document loss, and outdated or unverified information. Additionally, collaboration among multiple departments for file submission to regulatory bodies adds complexity.
To overcome these challenges, Promeditec offers the digital solution eDMR, a document management and approval workflow platform that simplifies and speeds up the preparation and management of technical documentation for medical devices.