RegMate QA is the intelligent platform being built for MedTech innovators. Get your initial regulatory assessment and roadmap using our guided workflow. Sign up for early access and be the first to simplify compliance and accelerate your launch.
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The traditional regulatory affairs model has several inefficiencies and cost reduction opportunities that AI is well positioned to address:
Regulatory expertise is concentrated among a small group of consultants who charge premium rates. RegMate's AIs democratize this knowledge by providing contextual, specific guidance at scale for a fraction of the cost.
Traditional regulatory processes rely on static documents that quickly become outdated. RegMate's AI's can continuously monitor regulatory changes, unpack the dense information, update their knowledge and automatically update guidance.
Compliance tasks are often sequential and manual. RegMate parallelizes these processes, automatically generating documentation, performing risk analyses, and identifying gaps.
As a MedTech innovator, you're likely facing these specific challenges:
Dense FDA regulations, the complexities of EU MDR, shifting standards – where do you even begin?
Expert consultants charge thousands, and generic QMS software doesn't understand your specific device needs.
One wrong step in classification, documentation, or testing can lead to months or years of delays and costly rework.
Building a compliant Quality Management System feels like a bureaucratic hurdle that slows down your actual product development.
Lack of confidence in your regulatory strategy spooks investors and partners, and keeps you up at night.
Sound familiar? A smarter way is coming.
RegMate QA goes beyond static checklists. We're building an interactive platform combining deep regulatory knowledge with intelligent, guided workflows to provide actionable insights precisely when you need them.
Receive a clear assessment of the likely regulatory pathway, applicable standards (FDA, EU MDR), and initial documentation requirements based on your device details.
Get an organized list of the key regulatory and QMS requirements you need to address, helping you plan your compliance journey.
Visually understand which requirements need attention based on your inputs, allowing you to prioritize effectively.
Experience an interactive workflow that helps you accurately define your device characteristics, ensuring the analysis is relevant.
Our vision includes seamlessly integrating Quality Management System (QMS) setup with your development milestones.
Quickly grasp complex requirements through AI-powered analysis and insights, reducing research time and reliance on expensive consultants.
RegMate QA aims to turn regulatory hurdles into a clear path forward.
Real-time regulatory pathway analysis
Our interactive workflow analyzes your device details (intended use, technology, etc.) to suggest the likely classification (e.g., FDA Class I/II/III, MDR Class I/IIa/IIb/III) and highlights the core regulatory requirements.
Benefit: Gain crucial early insights into your specific compliance needs and avoid strategic missteps.
Receive an organized output detailing applicable standards and regulations (e.g., ISO 13485, IEC 62304, 21 CFR 820, specific FDA guidances, MDR Annexes) grouped by area (QMS, Risk, Software, etc.).
Benefit: Get a clear, actionable plan outlining the necessary compliance activities.
A clear dashboard view highlights the identified requirements that need your attention based on your initial inputs.
Benefit: Instantly see where focus is needed for your compliance efforts.
RegMate QA aims to evolve to generate specific, prioritized compliance tasks linked directly to your development phases and integrate with project management tools.
Future Benefit: Stay organized with automatically generated, actionable steps throughout development.
Future enhancements will provide tools and templates to help you build out essential QMS procedures and records directly within the platform as you develop.
Future Benefit: Build an audit-ready QMS more seamlessly alongside your product development.
Advanced machine learning algorithm analyzing medical imaging for early disease detection, with real-time processing and cloud-based analysis.
Smart wearable device with embedded sensors and companion app for continuous heart rhythm monitoring and AFib detection.
RegMate QA is launching soon to provide MedTech startups with essential regulatory clarity. Sign up now to join our exclusive early access list.
We're excited to build this with you. Your insights matter.
Built by MedTech veterans and regulatory experts focused on practical solutions for innovators.