Companies seeking to get investigational and marketing approval authorizations for their medical devices must follow stringent application procedures, formats, and regulatory requirements and directives from global regulatory agencies such as the FDA CDRH, EMA, as well as other individual European and local country agencies.
Application submission structures such as the CTD help move the industry toward uniform submission standards, but the medical device industry still needs to support many different application formats across the globe.
The QUMAS solutions for R&D and regulatory document management is fully 21 CFR Part 11 compliant and provides a predefined set of content structures and templates to support the creation and management of the documents and content that comprise these submissions, including support for CTD, PMN / 510(k), PMA, and others. This solution is also designed to support all required formats and structures for the FDA, EMA, PMDA (Japan) and other global and individual country agencies and to allow integration with electronic publishing solutions for sending submissions to these regulatory agencies world-wide.
The QUMAS R&D Solution links document creation using Microsoft Word authoring templates and management to content gathering, tracking and submissions compilation for an efficient one-stop shop for submissions lifecycle management. By combining content authoring, content management, real-time collaboration and submission management, we provide one, integrated solution for all functional R&D areas. This solution includes but, is not limited, to Regulatory Affairs, Clinical, Nonclinical, and Quality. The solution is all inclusive — there is no additional sourcing, customization or additional integration required to immediately take advantage of a complete R&D strategy out of the box.
For more information, download the following webinars:
- Collaboration in R&D - From Content to Submission
- Managing Successful Submissions and US FDA Audits
- Regulatory Affairs and Quality Assurance Compliance on a Single Platform
- Qualifying SharePoint 2010 and Delivering a 21 CFR Part 11-Compliant Quality Management Solution