Complaint Handling and Adverse Event Reporting

New MDR Reporting to FDA and EU

Cloud and AI Excellence for Life Science and Healthcare

Medical Device Companies

Industry leading Solutions for Complaint Handling, Adverse Event Reporting, Field Notification Management, Risk Management and Product Registration Management

Digital Solutions Services

Implementations, Application Development, Migrations, Integrations, Data Warehouse and Business Intelligence, Machine Learning and AI

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Post Market Surveillance for the digital enterprise

Modern Post Market Surveillance

Do you spend most of your time in a system that is a glorified spreadsheet? Stop doing that and look at a system that actually makes your life easier. With automation that actually helps, and an innovative and trusted partner, medical device companies could spend more time with what they do best, design new products, communicate with regulators and help patients.

Our products are built on the most modern cloud

Built on Salesforce Platform and Google Cloud

Our customers get the security, functionality and availability of Salesforce.com and Google Cloud. Using the latest innovations from both cloud environments, Smarteeva provides ease of use, fast deployment and a long term partnership in both delivered functionality and daily support.

Smarteeva has delivered the most advanced Complaint Handling and Post Market Surveillance tools in the market today

100% Secure

Built on the secure Salesforce Platform Smarteeva offers both encryption on transit and encryption at rest. This is in addition to all the detailed and granular access rights that can be provided to users.

Any device

Smarteeva is able to be accessed from any device and usable anywhere. These are some of the benefits of the modern cloud applications

Industry Leading

Utilizing industry leading features such as client side validation checks, smart audit trail, sophisticated decision trees and machine learning, Smarteeva leads the industry in features, functionality and business support.

Smart Complaint Handling

Most systems out there provide spreadsheet level functionality, just collecting data without actually giving users the information that is in that data. Smarteeva is built differently, it makes it easy to collect data but at the same it provides for wisdom to be gleaned from that data.

Latest News

FDA Received over 2 Million MDRs in 2021
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FDA Received over 2 Million MDRs in 2021

News

FDA Received over 2 Million MDRs in 2021

Smarteeva Admin2022-03-09T13:58:59+00:00March 8th, 2022|News|

FDA Received over 2 Million MDRs in 2021 The Coronavirus pandemic did not stop the growth of MDRs

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Patient Infections reported to FDA have increased greatly in the past 10 years

Smarteeva Admin2021-01-05T07:15:22+00:00January 5th, 2021|News|

Patient Infections reported to the FDA are showing an increase in both absolute and relative numbers. Specifically, over

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MDR with Cerebrovascular Accidents/Strokes have been increasing especially in the past 3 years

Smarteeva Admin2020-12-14T18:38:03+00:00December 14th, 2020|News|

MDR submitted to the FDA are showing an increase in the number of patient strokes (Cerebrovascular Accidents/CVA). The

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Talk about solving our problem. We needed a Complaint Handling and Adverse Event Reporting implemented quickly. Smarteeva came through. They implemented and validated our system within 30 days.

CEO, EU Region Medical Device Company

Smarteeva was able to automate and simplify our complaints process. Not only did we become a lot more compliant, our lives got a lot easier once Smarteeva went live

Post Market Surveillance Manager, Global Medical Device Company

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