Benefit from automated solutions for complaints handling and adverse event reporting.
Smarteeva’s automated solution streamlines the end-to-end product registration process while providing comprehensive management of product portfolios with worldwide visibility.
Use advanced analytics to generate PSURs and other regulatory documents effortlessly.
Get real-time tracking and intelligent follow-up forms through Smarteeva’s exclusive platform.
Access detailed medical device safety data from MAUDE, Recalls, Warning Letters, FAERS, and beyond.
A top producer of glucose monitoring systems required a robust system for post-market surveillance and complaint management, handling 3 million complaints and 300,000 MDRs annually. Smarteeva stepped in to provide a scalable, unified solution that addressed their high-volume challenges.
A global medical technology company required a streamlined digitized system for speedy product registration, product status, expiration date tracker, Country requirement group all together. The company manufactured both diagnostic and therapeutic products that made tracking the entire product portfolio in a single application a challenge for the customer along with cost and time maintenance.
With Smarteeva’s Post-Market Surveillance (PMS) reporting, medical device safety and performance are continuously monitored. Beyond meeting regulatory requirements, our system helps improve device quality by generating key reports such as PSUR, PMSR, HCSR, PMPF-ER, and PMCF-ER. The platform simplifies report planning, grouping licensed products for efficient and organized submissions.
By leveraging Smarteeva’s organized and enriched data lake, Medical Device companies can simplify research, literature reviews, and compliance reporting, reducing data collection and analysis time by hundreds of hours each year.
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.