The Business Challenge:

Our client’s regulatory professionals face a myriad of challenges due to the complex and ever-changing nature of the medical technology industry. Some of the key challenges they encounter include:
Changing Regulatory Environment: As new technologies develop and global health regulations change, the regulatory environment for medical technology is continuously changing. Keeping up with the latest standards and requirements can be difficult and time-consuming.

Multiple Regulatory Bodies Compliance: Medical device manufacturing companies frequently operate in multiple countries, each with its own set of legislation and regulatory bodies. Regulatory experts must handle
multiple regulations while also ensuring compliance with various authorities.

Solution:

Codelogicx has been the associated partner of them to build the product from scratch in collaboration with the founder and co-founder, our software development team created a full online solution to address these concerns in the form of the following:

Unique Device Identifier (UDI) is the standard for tracking and managing medical devices in many major markets throughout the world. Each major market maintains its own UDI requirements; however, many
overlap with one another and maintaining this information correctly is a regulatory challenge. The system provides a consolidated list of UDI requirements per market, as well as identifying “Universal Fields” across the markets.

Codelogicx built the product from scratch using structured and dynamic tech stacks like:

Vue.js
NUXT front end, a progressive Vue.js framework
Axios to communicate with our API
Back end – Laravel
PHPUnit, Frameworks for Unit Testing
Automation Testing for Multiple Versions of the software using Selenium with Java, Cypress with JavaScript, Selenium and Python (Robot Framework)
Hosts the app on cloud AWS EC2s as well as EKS clusters, media is stored on S3 buckets
Database: MySQL and PostgreSQL for databases
Align with AWS best practices official guidelines,
Automated deployments via CI/CD