Medical Device companies operating in today’s highly regulated environment need comprehensive electronic document and content management systems and solutions that deliver robust functionality and support full compliance with ISO and regulatory requirements such as ISO 13485 and 21 CFR Part 11, yet they must still be easy to use, intuitive, and provide fast access to information. These systems must also be able to integrate with other 3rd party platforms for electronic publishing and submission to regulatory agencies world-wide, supporting all required formats and structures for the FDA, EMA, PMDA (Japan) and other global and individual country agencies. This includes supporting various formats and requirements such as PMA and 510(k) in the US, and also European directives such as Directive 93/42/EEC for Medical Devices and Directive 93/68/EEC for “CE Marking”.
The QUMAS R&D Solution provides a set of predefined structures, templates, workflows, business rules, and powerful collaboration and search and query capabilities designed to address the specific needs of the Medical Device industry. These solutions provide streamlined and efficient process for collaborative authoring and review cycles, allowing internal and external stakeholders to review, comment, propose changes, and approve critical and sensitive documents in an efficient and timely manner, with full compliance and audit controls and reporting capabilities automatically built in. These predefined regulatory offerings deliver an out-of-the-box solution for Medical Device regulatory document management needs that implements and validates quickly and easily.
Download this webinar on Managing Successful Submissions and US FDA Audits to hear best practice measures that companies need to have in place to mitigate negative inspection results. With the decision of the US FDA not to accept paper based submissions from January 1, 2015, this webinar outlines what you need to do when preparing electronic dossiers for the FDA. It highlights best practices to ensuring accurate submission content to significantly reduce agency approval time.