Regulatory compliance is a crucial part within Life Sciences and for manufacturers. Since requirements change constantly, multiple back-end systems are involved but are rigid, and fees of non-compliance are high. Having a flexible app platform to tackle these requests, like Mendix, is very powerful.
A specific app tracks the regulatory compliance around bribing and provides transparency of medical device manufacturers’ spending towards physicians, called Physician Payments Sunshine Act and HCP Aggregate Spend. Mendix low-code technology sits on top of ERPs, i.e. SAP, and reimbursement software like Concur, to rapidly aggregate, process the data based on specific business rules and report the data back to the government in order to comply.
Pre-market submission orchestration
Typically, these apps are part of a bigger process of registering and tracking medical devices and pharmaceutical products throughout the life cycle. TimeSeries can support you in all these areas from pre-market submission orchestrations for safety validations, risk reporting and case management, all the way to after services and warranty management, i.e. tracking warranties of millions of medical devices globally.
For a top-5 global Medical Device company registrations and tracking medical devices was a challenge due to localization needs, i.e. patients data could only stay within the patients country. Given the deployment flexibility (including on-premise or any cloud) of the Mendix platform one templated solution was developed, customized per region and deployed locally.,