Designed exclusively for Medical Devices by Regulatory & QMS experts
1. Errors & Oversight
Manual entries, scattered documents, and repetitive tasks create multiple points of failure, leading to data discrepancies and non-compliance.
2. Disconnection
Existing eQMS solutions lack the traceability and inter-departmental communication that a software solution should provide.
3. Audit & Inspection Issues
eQMS softwares working on disconnected modules often lead to departmental silos and lack of traceability leading to non-conformances.
4. Time & Resource Limits
Startups and small-to-mid-sized manufacturers often lack dedicated QA/RA staff. Startups spend 6-8 months creating a QMS and still risk audit failures.
Unlike current eQMS tools that operate with disconnected modules, siloed data, and no real-time cross-departmental sync often requiring manual cross-linking and leaving teams unprepared for inspections, Regtech delivers a unified, audit-ready platform built for seamless collaboration and compliance that mirrors the cross-functional reality of ISO 13485. Rather than isolating workflows into rigid modules, Regtech offers seamless, logic-driven processes that unify all departments within a single intelligent system.
Experience true inter-departmental connectivity through a unified QMS dashboard. Regtech brings your daily operations, data, and decisions into one integrated space — empowering faster, smarter, and fully compliant execution. Customize your dashboard by department, role, or focus area, so you always see what matters most.
Regtech replicates your SOPs with precision ensuring no step is skipped, no action goes unrecorded.
Every process flows through a defined, compliant path, automatically capturing non-conformances, triggering CAPAs, and driving continual improvement.
Stay audit-ready with clean, searchable audit trails.
With Regtech, compliance doesn’t stop when you step away. Access your Quality Management System in real-time from any location. It empowers leadership to make strategic decisions based on live data, without being on the shop floor.
Whether a document is awaiting your approval or if a production batch is ready for Quality Control testing or you have CAPAs that are open, you get automated, role-specific notifications to ensure you act on tasks that truly need your attention.
Smarter Tools for Every Team Member
Smart production planning, auto-generated material requisitions, and automated inter-departmental register updates. Complete transparency, from input to output. Non-conforming devices are automatically flagged in the NC Register so that you can easily categorize items as “Rework or Reject” based on your assessment. Spilt your BMRs with Regtech’s automated calculations and batch adjustments
Automated AQL sampling, schedule-based calibration prompts, and automated deviation reporting against acceptance criteria. Complete visibility with real-time non-conformance logs so you can quickly track issues as they arise. Plan your QC activities based on real-time tracking of production processes and ensure compliance at every stage. Automise reporting and stay ahead with faster corrective actions.
Get auto-reminders for validations and alerts for line-clearance. Quickly generate quality procedures using basic information, with document numbers and revisions automatically applied according to set controls. Track all open tasks from audits, reviews, and quality processes, and turn them into an organized, actionable To-Do list for easier management and faster follow-up.
Automatic MCQ evaluation and result generation, ePapers specific to each training session, and retraining triggers for failed trainees ensure learning gaps are quickly addressed. Attendance sheet accessibility windows keep records up to date. A built-in organogram makes it easy to assign access, manage roles, and track ownership across teams seamlessly and efficiently.
Live dashboards, manufacturing trends, data analysis, KPIs, audit performance, post-market feedback, and customer complaints—all at a click without needing to be on the shop-floor. Get instant insights, track performance metrics, and identify issues in real time so you can make informed decisions and improve operations from anywhere, anytime.
Procurement process at your fingertips. From analysing real-time supplier performance data to tracking purchase order lifecycles, you can ensure cost-effective, on-time, and quality-controlled sourcing. Manage your supply chain with complete transparency, monitor vendor compliance, and make data-driven decisions.
“Get role specific notifications & alerts using Regtech”
Our process
We design, develop, and implement automation tools that help you work smarter, not harder
We analyse the roles undertaken by the organisation, systems implemented, processes defined, manufacturing flow and lay down a customised plan to provide specific solution. Easily adapt the system to your organization’s size and needs, whether a startup or multinational enterprise
Our Team then builds your smart eQMS tailored to your systems and processes.
Our solutions are compatible and seamlessly integrate with ERP, LIMS, HRMS, and other enterprise systems via open APIs. Enable secure collaboration across locations with role-based permissions and cloud access.
Once the software is ready, our QA experts and IT developers ensure a smooth transition and implementation on-site for its effective and optimised usage.
Our evolving software is continuously upgrading itself based on user experiences, updated regulations and standards and state of the art practices offering our client an opportunity to evolve with it.
Our MOAT
Operations Lead at Flowbyte
“Truly impressive. The AI assistant is fast, accurate, and blends into our daily ops without friction.”
CTO at Brightstack Labs
“Game-changer. Automation flows run flawlessly. Our team now focuses only on what really matters.”
Product Manager at Nexora
“Smooth setup. Their system replaced three tools. We saw improvements in just the first week.”
Marketing Director at OrbitShift Director
“Surprisingly simple. The AI adapts quickly. Our campaigns are now running 2x more efficiently.”
Analytics Manager at Corelink
“Huge time-saver. Data is better organized. The insights we get now are actionable and fast.”
COO at PixelNest Solutions
“Very intuitive. No fluff, just performance. Our internal processes finally feel under control.”
Schedule a Call and Begin Automating
demo@mavenregtech.com
Find quick answers to the most common support questions
Still have questions? Feel free to get in touch with us today!
Yes. RegTech offers integration capabilities via secure APIs. It works with ERP systems, HR tools, training platforms, and analytics dashboards. If you need something custom, our team can support that too.
We offer onboarding assistance, regulatory consulting, detailed user manual and flow-specific videos. You’ll never be left figuring things out alone.
We specialize in automating repetitive workflows across operations, marketing, sales, and customer support using AI and custom logic.
We specialize in automating repetitive workflows across operations, marketing, sales, and customer support using AI and custom logic.
We specialize in automating repetitive workflows across operations, marketing, sales, and customer support using AI and custom logic.
We specialize in automating repetitive workflows across operations, marketing, sales, and customer support using AI and custom logic.
We specialize in automating repetitive workflows across operations, marketing, sales, and customer support using AI and custom logic.
