Designed For Medical Devices By Regulatory & Quality Experts
We didn't build RegTech to be just another QMS tool. We built it because we've lived the stress, the errors, the spreadsheets, and knew there had to be a better way.
RegTech is our answer: Thinks like an auditor, adapts like a consultant, and empowers teams to own their compliance. A solution designed to mirror how processes actually function in the medical device industry.
Product features that will enhance team productivity
Smarter Tools for Every Team Member
Production
Smart production planning with auto generated material requests and automatic updates across departments. You get full visibility from start to finish. Any non conforming devices are automatically flagged in the NC Register, making it easy to mark items as rework or reject based on your review. Manage and split BMRs easily using RegTech’s automated calculations and batch adjustments.
Quality Control
Automated AQL sampling, scheduled calibration reminders, and automatic deviation reporting based on acceptance criteria. Get complete visibility with real time non conformance logs so you can track issues as they happen. Plan QC activities using live production data and ensure compliance at every stage. Automate reporting and act faster with quicker corrective actions.
Quality Assurance
Get automatic reminders for validations and line clearance alerts. Create quality procedures quickly using basic inputs, with document numbers and revisions applied automatically based on defined controls. Track all open tasks from audits, reviews, and quality activities in one place and convert them into a clear, actionable to do list for easier management and faster follow up.
Human Resources
Automatic MCQ evaluation and instant result generation, along with ePapers tailored to each training session, and retraining triggers for failed trainees help close learning gaps quickly. Attendance sheets are available within defined time windows to keep records accurate and up to date. A built in organogram makes it easy to assign access, manage roles, and track ownership across teams smoothly and efficiently.
Top Management
Access live dashboards, manufacturing trends, data analysis, KPIs, audit performance, post market feedback, and customer complaints all in one place, without being on the shop floor. Get instant insights, monitor performance metrics, and spot issues in real time so you can make informed decisions and improve operations from anywhere, at any time.
Purchase
Manage your procurement process in one place. Analyse real time supplier performance, track purchase order lifecycles, and ensure cost effective, on time, quality controlled sourcing. Get complete visibility into your supply chain, monitor vendor compliance, and make data driven decisions with confidence.
Our MOAT
Why choose us over others?
- First ever Unified eQMS
- Customisable to the simplest daily tasks
- Fast setup with built-in templates
- Real-time reporting and analysis
- Automated task reminders
- Inter-linked Inter-departmental processes
- Systems are always audit-ready
- Fragmented modules
- Limited customisation
- Slower execution
- Limited or delayed reporting
- Only for data entry
- Lack of departmental connectivity
- Poor traceability leading to audit failures
Ready to Automate Smarter?
Let’s Build Together
Schedule a Call and Begin Automating
demo@mavenregtech.com