RegMate QA is the intelligent regulatory platform being built for MedTech innovators like you. Get notified for early access and be the first to simplify FDA & MDR compliance, integrate quality management, 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Traditional regulatory processes rely on static documents that quickly become outdated.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 is being designed as more than just another QMS tool or a static database. We're combining deep regulatory expertise with intelligent automation to give you active guidance precisely when you need it.
Instantly understand the specific regulatory pathway, standards, and documentation required for your device and target markets (FDA, EU MDR, etc.).
Build your ISO 13485 / FDA QSR compliant Quality Management System organically as you hit development milestones – no more bolted-on compliance.
Translate complex regulations into clear, prioritized tasks assigned directly within your workflow. Know exactly what to do next.
Access the insights of a seasoned regulatory consultant embedded in an intuitive platform, at a fraction of the cost.
Avoid common pitfalls and costly submission errors with AI-driven checks and validated templates.
Shave months off your regulatory journey by streamlining documentation, ensuring completeness, and preventing delays.
RegMate QA aims to turn regulatory compliance from your biggest roadblock into your strategic advantage.
Our platform will analyze your device details to identify your likely classification and the specific regulatory requirements (FDA/MDR) you need to meet.
Intended Benefit: Eliminate guesswork and costly strategic errors.
RegMate QA will generate a tailored roadmap of compliance tasks linked to development phases.
Intended Benefit: Stay organized and focused on clear, actionable steps.
Tasks will guide you through creating essential QMS procedures and records as you develop.
Intended Benefit: Be audit-ready faster with a QMS built seamlessly alongside your product.
Access templates for critical regulatory documents with embedded instructions.
Intended Benefit: Create accurate, compliant documentation efficiently, reducing errors.
RegMate QA is launching soon to revolutionize how MedTech startups handle regulatory compliance. Sign up now to join our exclusive early access list.
We're excited to build this with you. Your insights matter.
Developed by MedTech veterans and regulatory experts passionate about helping innovators succeed.