Smarteeva combines 100+ years of collective Medical Device expertise with advanced cloud software to deliver AI-driven compliance automation. Today, 30% of FDA MDR submissions are powered by Smarteeva, demonstrating industry trust. Our AI streamlines regulatory workflows, automating up to 60% of complaint processing, enhancing efficiency while maintaining accuracy.
Medical device reporting is growing rapidly, but you don’t need a larger team to keep up. Smarteeva automates your post-market surveillance, making it 40% faster. With instant AI-driven summaries, smart risk assessments, and automated reporting, Smarteeva simplifies every step.
Smarteeva’s solutions are built to support the specific requirements of your medical device company.
This app has been so helpful in improving our regulatory compliance! It’s transformed our company organization, ensuring seamless adherence to regulations. The intuitive interface and robust features have made compliance a breeze, significantly improving our workflow.
Anita’s wealth of experience in spearheading initiatives for customer success, delivery, HR, finance, and quality positions her as a highly accomplished professional with a proven track record of driving business growth. As a key founding member of Smarteeva, she was instrumental in designing and implementing robust systems and processes that facilitated the company’s seamless transition into a more mature organization. Her strategic vision and expertise have been pivotal in achieving exceptional levels of customer satisfaction and organizational success.
With 20 years of experience in the medical device industry, Plarent has a proven track record of building and leading global implementations of complaint handling and adverse event reporting systems. He is also the founder of two successful companies that have developed cutting-edge products. One of these products is a software solution used in cardiac catheterization labs, while the other is a Salesforce-based quality management system that is widely adopted by leading life science companies across the globe.
