Smarticus By Thinkerton

Thinkerton helps Regulatory Affairs and Quality professionals reclaim the hours wasted on the collection of data for critical regulatory documents - without compromising compliance. Regulatory Affairs teams continue to face mounting pressure from increased global requirements, various timelines, and growing workloads as companies continue to sell into new markets. Collecting data from multiple databases, completing data analysis, and drafting regulatory documents such as PSURs and PMCFs take up valuable time which could be spent on continuous improvement. Smarticus can create fully compliant draft PSURs for each device in your portfolio in seconds! Replacing hours of work with seconds of analysis and drafting to generate compliant and Ready-for-Review PSURs, leaving team members time to focus efforts on to meaningful work. Smarticus creates draft reports which are- Compliant to the EU and UK MDRs - In the recommended MDCG format, with annual reports created as needed - Team time savers Regulatory Professionals choose Thinkerton for many reasons: 1. Built specifically for the medical device and pharma industries 2. Designed to save time and reduce errors 3. Intended to support, not replace, quality and regulatory judgement We are committed to building the tools necessary to work efficiently and effectively in a regulated industry. Thinkerton provides solutions to allow you to focus on continued improvement.