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

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

MDR submitted to the FDA are showing an increase in the number of patient strokes (Cerebrovascular Accidents/CVA). The increase is in both absolute and relative numbers. Specifically, over the past 10 years the number of strokes reported has increased an average of 17%. If you narrow the range to the past 3 years only, the

Patient Deaths decreasing as percentage of MDRs

By |2020-12-08T18:27:47+00:00December 8th, 2020|News|

Medical Device Reports (MDRs) are typically required to be submitted to the FDA within 30 days of Complaint Awareness. FDA utilizes a variety of Code Types to classify these MDRs. One of these code types is Patient Code which is being split into Health Effect - Clinical Codes and Health Effect - Impact Codes. One

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

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