The Pulse of Medical Device Performance

Problems & Solutions

Customer	Customer Problems	MDRisks Solutions
Health Care Provider (e.g., Device User Facility, Specialist, Nurse)	Lack of access to high quality medical device performance information	✓ Efficient, intuitive, and holistic device analytics ✓ Relevant device recall alerts automatically communicated
	Medical device complaint reporting process is inefficient, time-consuming, and static	✓ Efficient and intuitive complaint reporting process ✓ Enhanced used device trackability & traceability
Medical Device Manufacturer	Incomplete and time-consuming medical device complaint processing	✓ Efficient and intuitive complaint reporting process
Medical Device Manufacturer	Lack of efficiency when alerting recalls	✓ Efficient and automated process to issue device recalls
Patient	Unaware of the options of devices that are available	✓ Accessible data on commercialized devices
Patient	Lack of access to high quality medical device performance information	✓ Efficient, intuitive, and holistic device analytics ✓ Relevant device recall alerts automatically communicated
Insurance Company	Lack of access to high quality medical device performance information	✓ Efficient, intuitive, and holistic device analytics

Our Technology

MDRisks System

An integrated web application optimized for desktop operating systems and intended to provide a superior solution to Post-Market Surveillance of medical devices.

b

Device Reporting Tool (DRT) & used Device Dashboard



Device Analytics
Dashboard



Device Recall
Alerts

Device Reporting Tool (DRT) & Used Device Dashboard

Today’s challenges

Federal regulations require device user facilities to report certain medical device events, which need to be investigated in a timely manner by the medical device manufacturer. The current methods to complete this process are highly inefficient, resulting in complaints being alleged with incomplete information, a longer complaint investigation process, added costs, and inadequate information to act upon.

How MDRisks can help

Our DRT helps health care providers (HCPs) to more efficiently capture medical device data in the clinical setting, starting from when the device is still in its packaging just before use to when there is a device-related event, if any. This is a software application that can optionally read the barcode on medical device labeling.

Data submitted through the DRT will get transferred to Used Device Dashboards. This will allow relevant parties (e.g., HCP and device manufacturer) to maintain traceability and trackability to devices that have been used.

Device Analytics Dashboard

Today’s challenges

There is lack of access to efficient, intuitive, and holistic medical device performance information (e.g., rate of failure and severity of harm).

How MDRisks can help

The medical device data that is collected through the MDRisks DRT will also be transferred to the MDRisks Analytics Dashboards in real-time, providing medical device performance analytics.

Device Recall AlertS

Today’s challenges

When a medical device is recalled, users and patients are typically informed too late or not at all.

How MDRisks can help

Our DRT will automatically notify the HCP if a particular device that is about to be used is in scope of a recall. The recall information goes as far back in time as possible and is updated weekly.

About MDRisks

MDRisks is a medical device performance communication company composed of a diverse team of professionals, including medical device quality engineers, a medical doctor, and software technologists.

our Mission

It’s our mission to improve clinical outcomes, regulatory compliance, and customer satisfaction through high-quality and efficient communication of medical device performance information and real-time analytical feedback.