Device Lifecycle Management for Life Science and Healthcare Industries
The Industry Challenges
Postmarket device lifecycle management and its applicable business processes pose an on-going challenge to medical device companies across the globe resulting in increased risk and overall liability. Such challenges include, but are not limited to:
Regulations continue to change and shift requiring medical device companies to adopt quickly or face non-compliance. The 2017 revision of the EU MDR is an example of a major regulation most companies need to adapt to.
The number of stakeholders involved in the delivery and management of devices continues to increase and expand across borders requiring tight collaboration between multiple parties more than ever.
Customers are more knowledgeable and educated these days demanding faster and more streamlined communication options with device and other postmarket service providers.
Smarteeva's solutions support the new Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) including the European Databank for Medical Devices (Eudamed).
Smarteeva Customer Portals
Built on top of the Salesforce Communities Platform, the Smarteeva Customer Portal is a solution that provides medical device customers with an in-depth view and analysis of their current client install base. The solution provides real-time access to overall customer information, account health, status of events (Complaints, recalls and more) in one single and easy to use place. The solution is accessible via any type of device, whether stationary or on the go for maximum convenience and faster responses. This is customer service at its best.
Smarteeva Intake and Complaints Solution
Smarteeva’s Intake and Complaint Solution provides the next generation of complaints management by fully integrating risk management and customer self service. Utilizing embedded Artificial Intelligence, the solution lets you collect all necessary and complete initial complaint data, followed by the ability to run automated risk assessments to help determine the level of risk associated with the complaint. Furthermore, leveraging machine learning capabilities, the solution guides the users through the right investigation and assessment path to ensure a complete feedback loop and compliance with regulatory authorities such as FDA, EU, PMDA, TGA etc.
Smarteeva Risk Management Solution
The Smarteeva Risk Management Solution embeds a state of the art approach to managing risk in general and FMEA in particular as they pertain to various internal and external product related events. The Smarteeva Risk Management solution is seamlessly integrated with the Intake and Complaints solutions enabling real-time risk assessments and subsequent risk mitigation activities. The solution supports root cause analysis and any follow-up actions required.
Smarteeva Recall Management (RM) Solution
Recall management is a common and necessary business process in the life science industry. The ability to promptly notify customers about a service, quality or product safety issue is key and is highly contingent on the availability and effectiveness of your customer data. Smarteeva takes recall management to a different level by providing each customer with an out-of-the-box ready customer feedback and notification portal. It manages all necessary correspondence automatically and is fully integrated with your complaints, risk management and device troubleshooting and investigation solution. The Smarteeva Customer Portal is powered by the Artificial Intelligence ready Smarteeva Platform.
Smarteeva Smart Audit Trail
The Smarteeva Smart Audit Trail engine takes activity tracking to a different level. No more static type of tracking which is common with most audit trail tools available, Smart audit trail can display all pertinent changes to data records including any related records. Moreover, the audit trail can be defined to track and flag "meaningful data changes" which make it easier to sift through large quantities of data enabling users to focus on what is important vs. not. Leverage your Audit trail as a key business decision tool not just a byproduct of data capture.
The Smarteeva Platform is the engine powering all Smarteeva applications. A modern platform built on top of the most modern cloud architecture - force.com - it is THE most modern way for medical device companies to manage post market business processes in the digital age. The Smarteeva platform consists of the following core functions, available to all other solutions:
- - Smart Audit Trail Engine
- - Workflow Management Engine, fully compliant with 21 CFR part 11
- - Electronic signatures
- - Artificial Intelligence based bots
- - Machine learning driven decision trees
- - Smart and dynamic Data Capture
- - Built-in integration tools
- - (EU) 2017/745 (MDR) and (EU) 2017/746 Support
- - Eudamed database integration
- - ISO 13485(2016) compliance
A fully connected cloud solution that leverages intake data at its source coupled with expert product knowledge. Enabling real-time information flow for improved business processes.
With our Knowledge Management applications, You can track your products for total device lifecycle visibility.
With the ability to pinpoint event demographics and leverage smart workflow algorithms companies are able to improve their product portfolio and overall customer service.
Benefits of Smarteeva
Increased Customer Engagement
Today’s customers have the ability to communicate with life science companies via multiple channels. Having a portal and mobile presence allows life science companies to bring the regulated processes into the digital age and give choice to their customers to better communicate with them about recalls, complaints, notifications, service contracts, troubleshooting and investigations.
Today’s regulatory bodies require companies to be proactive with their product and process quality both pre and post market. EU MDR actually requires real time Risk Assessments. Smarteeva is built with the proactive compliance in mind by integrating risk management, customer feedback and automated data collection for complaints, investigations and recalls/notifications
How many times have customers asked your clinical or account representatives about the status of a complaint? They will never have to ask again because it is available to them via the customer portal.
Simplicity and Flexibility
Easy to use and flexible systems allow for better compliance. Smarteeva, from its Platform to Intake and Complaints to Recall management and Risk management is built to allow for ease of use of extreme flexibility. Business process change over time and we want to make sure that your system matches your process rather than vice versa.
Better Data Quality
Collecting the right data so that complaint investigations and root cause analysis is faster is of utmost importance for both operational efficiency and for risk management.
Processes like Investigations, Intake, Notification Feedback and Risk Assessments require for Consistency of data collected in order for them to be effective and truly data driven and digital. Smarteeva recognizes that and was built from the ground up with the goal of consistent data collection and analysis.
Smarteeva was born on the idea that Post Market Surveillance and lifecycle management of medical devices should be easy, fast yet comprehensive enough to address the most demanding regulations and compliance obligations. Since 2017, Smarteeva is on a mission to modernize Post Market Surveillance by modernizing the technology used by companies in this process while bringing together all stakeholders onto a single, easy to use and complete platform. Smarteeva’s suite of applications is continuously expanding to cover all Post Market Surveillance processes medical companies are facing from initial shipment of assets until they are disposed of or decommissioned.