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Can safety recalls be predicted by analyzing MDR data?

By |2020-11-30T15:33:39+00:00November 30th, 2020|News|

Can MDRs predict when and if a medical device recall will happen? Based on our analysis, one can sometimes tell if a medical device safety recall is about to happen by the sudden big increase in submitted MDRs. As an example, here are 2 separate recalls reported by Allergan in 2019. Recall 1: Because of

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

By |2020-10-29T03:30:54+00:00October 29th, 2020|News|

Smarteeva announced the release of its Winter 2021 Post Market Surveillance Suite. Santa Barbara CA - Smarteeva announced the release if it's Winter 2021 Post Market Surveillance Suite which will have enhancements to its Smart Complaint System, FDA MDR Reporting, EU MIR Reporting, and Recall Management. Some of these enhancements include, MDR QuickFill, EUMIR QuickFill,

INCREASING MDR VOLUME FOR MEDICAL DEVICE COMPANIES IN THE UNITED STATES

By |2020-08-24T22:48:27+00:00August 24th, 2020|News|

INCREASING MDR VOLUME FOR MEDICAL DEVICE COMPANIES IN THE UNITED STATES Changes in regulatory requirements in both the United States and Europe, along with an increase in healthcare utilization, have significantly increased the number of MDR reports sent to the FDA. New innovation is a necessity if companies want to effectively handle the onslaught of

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

By |2020-07-27T02:18:30+00:00July 27th, 2020|News|

Smarteeva announced the release of its Summer 2020 Post Market Surveillance Suite. Santa Barbara CA - Smarteeva announced the release if it's Summer 2020 Post Market Surveillance Suite which will have additional state of the art enhancements to its Smart Complaint System, HHE management, MDR Management, and Recall Management. Some of these enhancements include,

The Cloud, remote work and COVID-19

By |2020-04-22T04:41:04+00:00March 17th, 2020|News|

The Cloud, remote work and COVID-19 One of the big lessons of the social distancing and working from home has been the resilience of the cloud infrastructure and the benefit it has provided to the “Business Continuity” of both business but also schools, medical clinics and other public infrastructure. We are writing this as

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

By |2020-04-22T04:41:15+00:00February 19th, 2020|News|

Smarteeva announced the release of its Spring 2020 Post Market Surveillance Suite. Santa Barbara CA - Smarteeva announced the release of it's Spring 2020 Post Market Surveillance Suite which will have additional state of the art enhancements to its Smart Complaint System, HHE management, MDR Management, and Recall Management. Some of these enhancements include,

Smarteeva Continues to Innovate in Customer Service Integrations

By |2020-04-22T04:41:25+00:00February 2nd, 2020|News|

Smarteeva continues to innovate, investing heavily in the integration of their customers’ Customer Service and Complaint Handling processes. Post market surveillance systems, such as Complaint Handling, almost always work in tandem with other business tools such as Customer Service applications, ERP systems and Manufacturing systems. Complaint Handling, as a process, is an extension of

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