Journey through our treasure trove of resources

Use our blog posts, data sheets, videos, and whitepapers to learn about our commitment to simplifying life for medical device companies.

PSURs for Medical Devices: Key to Post-Market Surveillance and Safety

The Business Impact of a Great UI/UX

Product Registration Tracking for Medical Devices

Streamlining Regulatory Reports: The Global Maze for Medical Devices

Navigating the Recall Network with Smarteeva’s AI Technology

Smarter, Faster, Safer: Revolutionizing Complaint Handling with Smarteeva

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

Smarteeva Unveils MDREngine: A Cutting-Edge Medical Device Analytics Platform for All Skill Levels

Smarteeva announces the release of its Summer 2023 Post Market Surveillance Suite

Patient Problem Analysis as reported to the FDA in 2023

Infusion Pumps and its global issues

FDA gives the green light to a revolutionary Portrait Mobile Platform by GE Healthcare

Smarteeva announces the release of the Smarteeva Platform for the Medical Device Industry

Compliance functionality is not too different from commercial functionality

One of our customers just went live with Lightning in record time

Smarteeva releases its Winter 2020 Smart Complaint System to provide full EUMDR compliance for Medical Device Companies

Top 5 Trends in Post Market Surveillance

Smarteeva announces the release of its enhanced configuration administration capabilities

Smarteeva continues to innovate, investing heavily in the integration of their customers’ Customer Service and Complaint Handling processes

The Cloud, remote work and COVID-19

Increasing MDR Volume for Medical Device Companies in the United States

Smarteeva announced the release of its Summer 2020 Post Market Surveillance Suite

Smarteeva announced the release of its Winter 2021 Post Market Surveillance Suite

Top MDR Submitters 2010 – 2019

Can safety recalls be predicted by analyzing MDR data?

Patient Deaths decreasing as percentage of MDRs

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

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

FDA Received over 2 Million MDRs in 2021

2019-2022 Patient Problem analysis as reported to FDA

Medical Device related Patient Infections decreased by 31% in 2022

Smarteeva announces the release of its Summer 2023 Post Market Surveillance Suite

Top 5 Trends in Post-Market Surveillance 2023

Patient Deaths decreasing as percentage of MDRs in 2022

Top MDR submitters in 2022

The FDA received over 3 million MDRs in 2022

Smarteeva Platform Data Sheet

The Smarteeva Platform is the engine powering all Smarteeva Products. A modern intelligent platform built...

Smart Audit Trail Data Sheet

Smarteeva’s Smart Audit Trail organizations can quickly research and asses the state of their regulatory...

Field Notification Management

Smarteeva Field Notification Management provides end to end Notification Management functionality. Our next-gen solution delivers...

Risk Management Data Sheet

Smarteeva’s Risk Management Solution embeds a state of the art approach to managing risk in...

Customer Portal Data Sheet

Rapid globalization coupled with Todays intelligent customer require tighter collaboration across your organization through to...

Complaints Management Data Sheet

Complaint Solution provides the next generation of complaints and investigation management by fully integrating risk...

Smarteeva announces the release of the Smarteeva Platform for the Medical Device Industry

Santa Barbara, CA – Jan 10, 2019 – Smarteeva, Inc announced the recent release of the...

Smarteeva announces the release of its Summer 2023 Post Market Surveillance Suite

 Smarteeva, a premier post-market surveillance partner to global medical device companies, is excited to announce...

Top 5 Trends in Post-Market Surveillance 2023

At Smarteeva, we interact with numerous medical device industry insiders and pay attention to where...

Patient Deaths decreasing as percentage of MDRs in 2022

The FDA requires Medical Device Reports (MDRs) submission within 30 days of Complaint Awareness and...

Top MDR submitters in 2022

Smarteeva maintains an internal database of medical device adverse events. We use public data such...

The FDA received over 3 million MDRs in 2022

The Increase in the Volume of Complaints and MDR reports In the past 10 years,...

EU Incident Reporting by Smarteeva

Smarteeva delivers state-of-the-art simplicity with its newly released Manufacturer Incident Report for EU MDR

Smarteeva Post Market Surveillance and EU MDR Ready Suite

Smarteeva’s Postmarket Device Lifecycle suite of products provides an unsurpassed amount of efficiency with the...

Smarteeva Audit Trail – Quick Demo

Smarteeva’s Smart Audit Trail takes record tracking to the next level of usability and productivity....

Smarteeva – Smart Minute – Decision Trees

Smarteeva delivers smart decision trees for reportability assessments, questionnaires, guided forms, and checklists.

Smarteeva – Smart Minute – Smart Audit Trail

Smarteeva Changes How Medical Device Companies utilize Audit trails.