In the world of medical devices and IVDs, staying abreast of regulatory requirements is crucial. eStandards, our innovative solution, is designed to monitor your applicable regulatory requirements and automate the implementation process, ensuring you're always up-to-date with standards, legislations, guidances and your documentation.
eStandards automatically checks your applicable regulatory requirements and keeps them current in your Technical Documentation. You decide when to implement them. Whether it's a standard, a whole legislation, or MDCG guidance documents, eStandards has got you covered and knows where you mentioned it in your documentation.
Implementing new standards and guidances into your technical documentation has never been easier. With eStandards, you can write your Impact Assessments and approve your new regulatory requirement. After your digital approval, all impacted documents are ready for automatic updates.
eStandards is ready for content-based requirement management. It ensures that your documents, such as the list of applied standards, GSPRs, Design & Development Documents, and Clinical Evaluations, are automatically updated.
Are you ready to rethink regulatory compliance? Experience the power of automation with eStandards. Discover how our software can revolutionize your regulatory requirements process.
Want to learn more about automation of regulatory processes and technical documentation? Join the University!