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.

AI effects on employment – reviewing the Yale study

AI effects on employment – reviewing the Yale study

Inside Smarteeva’s Agentic AI

Inside Smarteeva’s Agentic AI

The State of AI After the MIT Report on 95

The State of AI After the MIT Report on 95

Closing the Loop: Turning Customer Insights Into Product Excellence

Closing the Loop: Turning Customer Insights Into Product Excellence

From Reactive to Proactive Post-Market Surveillance

From Reactive to Proactive Post-Market Surveillance

Smarteeva Announces API Integration Support for FDA’s Electronic Submissions Gateway Next Generation

Smarteeva Announces API Integration Support for FDA’s Electronic Submissions Gateway Next Generation

PMCF Simplified: AI-Driven Compliance & Smarter Monitoring with Smarteeva.

PMCF Simplified: AI-Driven Compliance & Smarter Monitoring with Smarteeva.

Gap Analysis & Insights with Smarteeva’s Recall Management

Gap Analysis & Insights with Smarteeva’s Recall Management

SmarteevaAI Platform – Smarter Automation Through Fine-Tuned AI

SmarteevaAI Platform – Smarter Automation Through Fine-Tuned AI

Top Patient Issues Reported to the FDA in 2024

Top Patient Issues Reported to the FDA in 2024

MDRs in Focus: The Surge, The Players, and The Trends

MDRs in Focus: The Surge, The Players, and The Trends

Beyond Code: Why Data, Domain Expertise, and Communication Drive AI Success in MedTech

Beyond Code: Why Data, Domain Expertise, and Communication Drive AI Success in MedTech

Top 5 Trends in Post-Market Surveillance 2024

Top 5 Trends in Post-Market Surveillance 2024

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

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

The Business Impact of a Great UI/UX

The Business Impact of a Great UI/UX

Product Registration Tracking for Medical Devices

Product Registration Tracking for Medical Devices

Efficient Regulatory Reporting: Managing Global Compliance for Medical Devices

Efficient Regulatory Reporting: Managing Global Compliance for Medical Devices

Navigating the Recall Network with Smarteeva’s AI Technology

Navigating the Recall Network with Smarteeva’s AI Technology

Smarter, Faster, Safer: Revolutionizing Complaint Handling with Smarteeva

Smarter, Faster, Safer: Revolutionizing Complaint Handling with Smarteeva

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

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

Smarteeva Announces Release of Its Summer 2023 Post-Market Surveillance Suite

Smarteeva Announces Release of Its Summer 2023 Post-Market Surveillance Suite

Patient Problem Analysis as reported to the FDA in 2023

Patient Problem Analysis as reported to the FDA in 2023

Infusion Pumps and Their Global Issues

Infusion Pumps and Their Global Issues

FDA Approves GE Healthcare’s New Portrait Mobile Medical Platform

FDA Approves GE Healthcare’s New Portrait Mobile Medical Platform

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

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

Similarities between Compliance functionality to commercial functionality

Similarities between Compliance functionality to commercial functionality

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

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

Smarteeva Releases Winter 2020 Smart Complaint System for Full EU MDR Compliance

Smarteeva Releases Winter 2020 Smart Complaint System for Full EU MDR Compliance

Top 5 Trends in Post Market Surveillance

Top 5 Trends in Post Market Surveillance

Smarteeva Announces Enhanced Configuration and Administration Capabilities

Smarteeva Announces Enhanced Configuration and Administration Capabilities

Smarteeva Continues to Innovate with Strong Investments in Integrating Customer Service and Complaint Handling

Smarteeva Continues to Innovate with Strong Investments in Integrating Customer Service and Complaint Handling

Post-Pandemic Innovation: How Smarteeva Leverages Cloud Tech and Remote Work for Growth

Post-Pandemic Innovation: How Smarteeva Leverages Cloud Tech and Remote Work for Growth

Rising MDR volume poses growing challenges for U.S. medical device companies

Rising MDR volume poses growing challenges for U.S. medical device companies

Smarteeva Announces Release of Summer 2020 Post Market Surveillance Suite

Smarteeva Announces Release of Summer 2020 Post Market Surveillance Suite

Smarteeva Announces Release of Winter 2021 Post Market Surveillance Suite

Smarteeva Announces Release of Winter 2021 Post Market Surveillance Suite

Top MDR Submitters 2010 – 2019

Top MDR Submitters 2010 – 2019

Can MDR data analysis help in forecasting potential safety recalls?

Can MDR data analysis help in forecasting potential safety recalls?

Patient deaths accounted for a smaller share of MDRs in 2022 than in prior years.

Patient deaths accounted for a smaller share of MDRs in 2022 than in prior years.

More MDRs are being reported for strokes, with a sharp rise in recent years

More MDRs are being reported for strokes, with a sharp rise in recent years

FDA-reported patient infections have grown dramatically in the last 10 years

FDA-reported patient infections have grown dramatically in the last 10 years

The FDA received more than 2 million Medical Device Reports (MDRs) in 2021.

The FDA received more than 2 million Medical Device Reports (MDRs) in 2021.

FDA-Reported Patient Issues: 2019–2022 Analysis

FDA-Reported Patient Issues: 2019–2022 Analysis

Patient infections linked to medical devices dropped by 31% in 2022

Patient infections linked to medical devices dropped by 31% in 2022

Top 5 Trends in Post-Market Surveillance 2023

Top 5 Trends in Post-Market Surveillance 2023

Patient Deaths Decreasing as a Percentage of MDRs in 2022

Patient Deaths Decreasing as a Percentage of MDRs in 2022

Top MDR submitters in 2022

Top MDR submitters in 2022

The FDA received over 3 million MDRs in 2022

The FDA received over 3 million MDRs in 2022

Automated Post-Market Surveillance Reporting

Automated Post-Market Surveillance Reporting

Smarteeva’s functionality transforms PMS reporting by automating the entire process, from data preparation to final...

Smarteeva Platform Data Sheet

Smarteeva Platform Data Sheet

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

Smart Audit Trail Data sheet by Smarteeva

Smart Audit Trail Data sheet by Smarteeva

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

Field Notification Management

Field Notification Management

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

Risk Management Data Sheet

Risk Management Data Sheet

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

Customer Portal Data Sheet

Customer Portal Data Sheet

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

Complaints Management Data Sheet

Complaints Management Data Sheet

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

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

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

Santa Barbara, 23rd Jan 2024 - Smarteeva, a leader in post-market surveillance solutions, is thrilled...

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

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...

Top 5 Trends in Post-Market Surveillance 2023

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 a Percentage of MDRs in 2022

Patient Deaths Decreasing as a 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

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 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.

Real world results from Smarteeva’s Embedded Agentic AI

Real world results from Smarteeva’s Embedded Agentic AI

PMS-Integrated Product Registration Tracking

PMS-Integrated Product Registration Tracking

From 100+ Hours to 8 Minutes: The New PMS Reporting Standard

From 100+ Hours to 8 Minutes: The New PMS Reporting Standard

The Digital Upgrade: Uniting Dynamics 365 CRM with Smarteeva’s Complaint Automation.

The Digital Upgrade: Uniting Dynamics 365 CRM with Smarteeva’s Complaint Automation.

The 95% Edge: Fine-Tuned AI Transforms Complaint Reviews

The 95% Edge: Fine-Tuned AI Transforms Complaint Reviews

One Link, Infinite Ease: Simplified Complaints Management

One Link, Infinite Ease: Simplified Complaints Management

Smarteeva’s Unified PMS Reporting

Smarteeva’s Unified PMS Reporting

Scalable Quality Management with Cost-Savings

Scalable Quality Management with Cost-Savings

Smarteeva’s GenAI Complaint Engine

Smarteeva’s GenAI Complaint Engine

Smarteeva solves High volume complaints handling challenges for a medical device company

Smarteeva solves High volume complaints handling challenges for a medical device company

Optimized Product Registration & Tracking

Optimized Product Registration & Tracking

Global Medical Device Company manages recalls with Smarteeva’s Post Market Platform

Global Medical Device Company manages recalls with Smarteeva’s Post Market Platform