From Manual to Machine: How Automation is Revolutionizing Post-Market Surveillance

Legacy Systems – The Bottleneck of Progress 

In the medical device industry, legacy systems represent a significant bottleneck, hindering efficiency and innovation. As an industry that’s inherently complex and tightly regulated, the incorporation of advanced technology is not just an advantage; it’s a necessity. These outdated systems are often siloed and lack the agility needed for the fast-paced regulatory environment, resulting in delayed response times, increased risk of non-compliance, and ultimately, a slower path to market for critical medical innovations. The reliance on manual processes not only drains resources but also introduces a higher margin of error, affecting overall product safety and efficacy.

The Dawn of Automation and Machine Learning 

The introduction of automation and machine learning into the medical device industry marks a pivotal shift. These technologies offer the promise of streamlining complex processes, from manufacturing to post-market surveillance. By automating routine tasks, companies can allocate more resources to innovation and strategic initiatives. Machine learning, in particular, provides the ability to analyze vast datasets, predicting trends and potential issues before they become problematic, thereby enhancing decision-making and operational efficiency. A recent survey by the Medical Device Innovation Consortium (MDIC) indicated that automated systems can reduce report processing times by up to 30%. Moreover, they can enhance accuracy in adverse event reporting, which is critical given that the FDA receives several hundred thousand medical device reports (MDRs) annually.


One of our customers reported “with Smarteeva’s automated systems, 60% of their complaints are now resolved through Machine Learning and AI with zero human interaction”. This truly depicts Smarteeva’s mission and is a remarkable achievement; when compared to typical industry standards. 


Redefining Post-Market Surveillance with Smarteeva 

Automation is redefining post-market surveillance duties, transforming them from a regulatory obligation into a strategic asset. Smarteeva is at the forefront of this transformation, leveraging the power of the Salesforce platform to provide an integrated, automated solution for the medical device industry. Our tools not only streamline the complaint handling process but also ensure compliance with global regulatory standards, all while enhancing product safety. With Smarteeva, companies can anticipate market needs, respond to feedback more effectively, and maintain a competitive edge in the rapidly evolving healthcare landscape. Our commitment to innovation is reshaping how the medical device industry approaches post-market surveillance, making it smarter, more efficient, and ultimately, more patient-centric. The automation revolution in the medical device sector is not just about keeping pace with technology. It’s about anticipating the needs of a growing industry, ensuring patient safety, and meeting the rigorous demands of regulatory bodies. As automation becomes more sophisticated, Smarteeva believes beyond just being a participant. Instead we are investing heavily into research and analysis of reshaping the medical device industry.  


About Smarteeva:

Based out of Santa Barbara, CA. Smarteeva Software provides cutting-edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance, organizational efficiencies and user-friendliness. Built on the Platform and utilizing the latest AI and Machine Learning innovations, Smarteeva Software is a true partner to its business users.

See how Smarteeva can help you make Post Market Surveillance faster and easier by going to our Product Page