Сompletion of the development of the new Digital Medical Device Quality System eMDD-RIMS

We announce the completion of the development of the new Digital Medical Device Quality System eMDD-RIMS.

eMDD-RIMS is a document management system for manufacturers, authorized representatives and distributors of medical devices that significantly simplifies the management of regulatory and quality documentation. The system allows you to create a centralized documentation repository with access for all employees, through which documents are developed, created, versioned and signed, task timing and control, training, etc.

eMDD-RIMS provides significant assistance to companies in automating the processes of preparing and maintaining documents regarding certificates and declarations of conformity, and other technical documentation in accordance with the selected procedure for assessing the conformity of medical devices.

eMDD-RIMS allows:

• Maintain a register of medical devices and their main characteristics;
• Track existing certificates, their expiration dates, and plan work in advance, including recertification of medical devices;
• Monitor existing medical device declarations, their expiration dates, and plan work in advance to maintain the relevance of documents;
• Digitize documents, quality management system and process management;
• Generate various printed forms of documents required during registration and conformity assessment of medical devices;
• Improve compliance with ISO 13485 and other standards;
• Ensure uniformity of information between documentation;
• Speed up and simplify labeling work;
• Automate processes, reduce risks and costs;
• Provide centralized storage of documentation, assign roles and provide shared access;
• Ensure transparency and control at every stage of work, reduce the time for coordination and approval;
• Avoid errors associated with manual document processing.

The system takes into account all requirements for electronic document management, in particular, it supports qualified electronic signature (QES).