logo
Business Type

B2B SaaS

Industry Type

MedTech / Medical Devices

Solutions by Codelogicx

Regulatory Platform, Document Repositories

Project Timeline

5+ Years

Project

Overview

It all started with the intention to remove the roadblocks in MedTech compliance…

Despite their work complexity and high stakes, most Regulatory Affairs teams still rely on outdated tools like spreadsheets, forcing them to build templates and track requirements manually. This consumes valuable time and resources and increases the risk of errors, making it harder to maintain compliance throughout the product's lifecycle.

With a vision to transform manual burdens into intelligent automation, Rimsys took shape, powered by the engineering expertise of Codelogicx. The result was an innovative, web-based platform that digitizes and automates regulatory processes within a single, unified cloud environment.

Since its debut in the MedTech industry, Rimsys has empowered regulatory affairs teams to work more efficiently, accelerate product launches, and significantly reduce the risk of non-compliance.

Technology

Stack

Frontend:

NUXT front end, a progressive Vue.js framework - v2.15.3

Backend:

Laravel - for our API - v8.34.0, PHPUnit

Database:

MySQL and PostgreSQL

Media Storage:

S3 Buckets

Web Servers:

EKS, EC2

Cloud Infrastructure:

Amazon Web Services (AWS) using EC2 instances

Data Backup:

AWS Glacier Vaults

Compliance & Governance:

AWS Well-Architected Framework

Project

Strategy

Our goal was to develop a centralized, cloud-based platform that empowers Regulatory Affairs (RA) teams in the MedTech industry to digitize documentation, automate workflows, and reduce time-to-market by streamlining compliance operations globally.

Strategic Vision: Digitizing Regulatory Complexity for MedTech Excellence

  • Centralized Information Architecture that serves as the “single source of truth” for submission data.
  • Workflow Automation & Efficiency by logic-driven workflows.
  • Localization & Compliance Readiness with the integration of country-specific regulatory entry requirements.

Guided by its vision to simplify complex enterprise workflows through intelligent digital solutions, Codelogicx partnered with Rimsys to reimagine regulatory affairs for the MedTech industry.

The approach focused on building a unified, cloud-based platform that digitizes documentation, centralizes compliance data, and automates key regulatory operations.

By aligning with AWS best practices, implementing agile development, and prioritizing user-centric design, Codelogicx delivered a scalable, secure solution that empowers RA teams to reduce administrative overhead, ensure global compliance, and bring products to market faster.

Ready to simplify

regulatory hassles?

Let's build the future of compliance together

Our

Solution

Regulatory Chaos Out, Intelligent Control In!

At Codelogicx, we engineered a cloud-native platform that empowers Rimsys to digitize, automate, and centralize regulatory operations. From global compliance to real-time collaboration, every feature was designed to reduce friction and accelerate product readiness.

Automated Workflows That Think Ahead

Codelogicx engineered a powerful automation engine to streamline regulatory processes, from document tracking to submission generation, dramatically reducing manual intervention and speeding up product approval cycles.

Centralized Data Repository for Global Teams

We built a unified, role-based platform where global RA teams could access, manage, and update regulatory data and documents with complete consistency, establishing a single source of truth for the entire organization.

Region-Specific Rules, Templates & Smart Monitoring

Codelogicx integrated country-specific regulatory frameworks, expiration alerts, and evolving legislation tracking, enabling Rimsys to adapt dynamically across global markets without compliance disruptions.

Scalable, Secure Infrastructure on AWS

Hosted on AWS EC2 with media in S3 and long-term backup via Glacier Vaults, the platform is built for high availability, security, and disaster resilience, aligning with AWS best practices and modern DevOps principles like CI/CD and regular patching.

Business

Outcomes

Transformative Outcomes for a New Era of Regulatory Management

As an avid believer in innovation, Team Codelogicx partnered with Rimsys to transform the fragmented world of MedTech compliance into a streamlined, data-driven ecosystem. The result? A powerful cloud-based platform that empowers regulatory affairs teams to operate faster, smarter, and with complete global visibility.

80% Reduction in Device Release Timelines

Automated workflows and centralized documentation significantly cut down approval and submission time, accelerating product launches.

Drastic Drop in Administrative Burden

Manual spreadsheet-driven tasks were replaced with intelligent tools, freeing RA teams to focus on strategy and compliance oversight.

Improved Global Regulatory Compliance

Real-time tracking of region-specific standards, expirations, and evolving regulations ensured uninterrupted market presence.

Increased Collaboration Across RA Teams

A single source of truth improved coordination, reduced redundancy, and ensured that teams across geographies worked with consistent, up-to-date information.

Scalable Infrastructure with High Resilience

AWS-hosted cloud deployment enabled secure, always-available access, with disaster recovery, data backup, and patching practices aligning to enterprise standards.

Accelerated Emergency Response During Crisis

During the COVID-19 outbreak in India, a leading in-vitro diagnostics manufacturer leveraged Rimsys to expedite regulatory clearance and shipment authorization. With all documentation centralized on the platform, the company bypassed typical import delays, enabling the swift delivery of critical diagnostic supplies when lives were on the line.

Simplified UDI Management Across Markets

Unified handling of Unique Device Identification (UDI) data by geography and product family improves traceability, speeds up registration, and supports regulatory transparency worldwide.

Streamlined GSPR/Essential Principles Mapping

Automated linking of essential principles and safety/performance requirements to submission documents accelerates market entry for medical devices while maintaining regulatory integrity.

Always Up-to-Date with Global Standards

Continuous monitoring of evolving standards (ISO, FDA, MDR, etc.) empowers companies to stay ahead of regulatory shifts, plan updates efficiently, and avoid non-compliance penalties.

Codelogicx is more like a natural extension of our team, so I rarely think of them as a vendor. The CX team continues to be an outstanding partner in the growth and evolution of our software platform and our company. They go out of their way to deliver valuable insights and quality solutions on an expedited schedule, helping to ensure we can meet or exceed our customers' needs. Our business would not be where it is today without the tireless contributions from Codelogicx.

Brad Ryba

Co-founder and CTO, Rimsys