DORA 360 vs. RegDesk Comparison Chart

Pros

• Comprehensive, user-friendly tool that consolidates all regulatory affairs processes in one place. Excellent support provided by real experts that add value to our business.
• The User Interface is very elegant and engaging to use. The Global view of Alerts, Standards and Regulations is appealing and consolidated and is a useful tool for regulatory intelligence.
• RegDesk is easy to deploy, entirely web-based with streamlined user access management. Its UI is intuitive which makes training users simple. Its modular structure reduces complexity for folks working on specific topics, which may not relate to the work of another colleague -- for example, Regulatory Intelligence and market access requirements appear in one module, while tracking submissions is in another. Additionally, tracking postmarket "where-can-I-ship?" elements is simple and straightforward with a SKU and country-code database.
• Compliance is critical in the medical device world to ensure safety of users and patients. Compliance tracking allows companies to establish and maintain a validated state of control, while looking at efficient ways to stay ahead of changing regulations. Documentation Management allows organizations to prepare for future growth by reviewing content from multiple dossiers and leverage similarities of content increase speed to submission. In many situations’ documents are updated as products progress through lifecycle and by managing documentation change electronically increases efficiency. Utilizing reporting and statistics during business planning allows Regulatory Affair heads to show organizations the return on investment for regulatory departments. Reporting on the number of requests, submissions, approved/cleared submissions and timelines allows key performance indicators to be develop. Being able to report on the number of international requests allowed for the organization to enhance their approach on global expansion. Easy to implement and utilize, customization and collaboration with RegDesk team, tracking to allow for reporting to organizations allowing for visibility of global changes/updates.