“Smart Automated Solutions Tailored to Every Department”
Because compliance is not one-size-fits-all, it’s built across your processes, teams, and systems.
At Regtech, we understand that every department has unique workflows and compliance challenges. That’s why our system is designed to work cross-functionally — ensuring seamless collaboration between QA, Production, QC, Purchase, RA, and beyond. Explore how Regtech transforms each department below.
Production
Quality control
Quality Assurance
Purchase
Human Resources
Store
eQMS solutions for Production department
Smart planning, auto-filled BMRs, and interlinked QC approvals.
Regtech (eQMS) transforms your production operations by aligning quality with execution. Designed with a deep understanding of medtech manufacturing, it empowers your team with intelligent tools to plan, monitor, and optimize production all while staying compliant to Quality Management System requirements.
Precision built in. Compliance built around.
Solutions for Medical Device QC/QA Teams
With Regtech, Quality Control (QC) teams don’t just check quality, they lead it. From automated AQL sampling to interlinked calibration tracking, our system ensures that your quality control is proactive, traceable, and audit-ready at all times. Real-time non-conformance logs and Auto-reminders for Validations to keeps your Quality Assurance (QA) teams ahead of deadlines.
Top Management
Smarter Oversight. Real-time Control. Strategic Quality Decisions.
Regtech equips your executive leadership with visibility and insights that go beyond dashboards — offering a powerful command center for proactive, data-driven quality governance.
- Data analysis tools within the eQMS help identify trends, monitor performance, and ensure compliance presented through a consolidated dashboard view for real-time visibility and informed decision-making.
· Real-time visibility into the status of each process and activity ensuring transparency, accountability, and streamlined quality management.
Competency, Awareness & Training
Regtech’s HR & Training Module empowers medical device companies to automate and streamline competency tracking. It enables trainers to create training-specific ePapers, auto-evaluate MCQ assessments, and trigger retraining for failed candidates. Smart scheduling ensures timely attendance capture, while grading logic ensures consistent evaluation — all fully integrated with your QMS records.
Internal & External Audit Ready:
You can give limited, read-only access to people outside your organization, like auditors or clients. They get isolated windows to review specific content without accessing the internal system. This supports compliance and transparency without compromising security.
Unified Task Dashboard
All open actions from audits, CAPAs, reviews, etc., auto-collected in one smart to-do list
Audit-Grade Traceability
Color-coded document change logs for quick audit reviews. Green = Added, Red = Removed.
Secure Archive System
Old documents never deleted, only moved to searchable archives for legal and audit needs.
Smart Role-Based Notifications
Only relevant users get alerts for create/review/approve actions — no noise, no delay.
Intelligent Data Portability
Bulk import/export records via Excel — ideal for migration or reporting.
Smart Document Generator
Auto-generate formatted SOPs/forms via guided questionnaire. Fast. Accurate. Consistent.
Custom Workflow Engine
No rigid templates. Flexible, conditional, multi-step flows tailored to your actual process.
End-to-End Traceability
Every record, form, and process is linked — ensuring full compliance visibility.
Sed ut perspiciatis unde omnis iste natus ut perspic iatis unde omnis iste perspiciatis ut perspiciatis unde natus. Sed ut unde omnis iste.
Megan Taylor
Sales Director
See it in action
Request a personalized demo
Experience how Regtech can simplify your QMS — from production to post-market. Get a tailored walkthrough based on your device type, compliance goals, and pain points.
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Built for Medtech Teams
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Audit Ready Real-Time Traceability
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Customised Automated QMS