Bringing ease
to MedTech
Turning Medical Innovation into Certified, Market-Ready Devices. Combine engineering expertise with AI-augmented quality & regulatory automation. From concept to certification swiftly—with confidence.
Built by people who worked at
From Challenge to Solution
Discover how we transform complex MedTech development challenges into streamlined, AI-powered solutions that accelerate your path to market.
MedTech Development Challenges
The path from medical device concept to market is complex, time-consuming, and costly.
Complex Regulatory Requirements
Navigating FDA, ISO 13485, and international standards requires deep expertise and extensive documentation.
Time-Intensive Documentation
Creating comprehensive DHF, DMR, and QMS documentation can take months or years of manual work.
High Development Costs
Traditional development processes can cost millions and take 3-7 years to reach market.
Limited to SaMD Solutions
Most AI tools only support Software as Medical Device, leaving physical devices underserved.
The Regulify Solution
We combine hands-on engineering expertise with AI-augmented automation to solve these challenges.
AI-Powered Documentation
Automated generation of DHF, DMR, and QMS documentation reduces manual work by 50%+.
End-to-End Expertise
From concept to certification, we provide comprehensive support for all medical device types.
Faster Time to Market
Streamlined processes and AI automation significantly reduce development timelines and costs.
Universal Device Support
Works with ALL medical devices - from simple instruments to complex implantables and SaMD.
Key Differentiator
Unlike other solutions that focus only on SaMD, Regulify works with ALL medical device types - from simple surgical instruments to complex implantable devices and software solutions.
Comprehensive MedTech Products
From initial concept to market launch and beyond, we provide end-to-end support for all your medical device development needs.
Pre-Sub Accelerator
Strategic guidance for FDA pre-submission meetings.
Navigate the pre-submission process with confidence. Our Pre-Sub Accelerator helps you prepare comprehensive meeting packages, develop effective regulatory strategies, and optimize communication with FDA reviewers to ensure the best possible outcome for your submission pathway.
Need a Custom Solution?
Every medical device is unique. We tailor our products to meet your specific requirements and regulatory needs.
Discuss Your ProjectYour Development Journey
We support you at any stage of product development with our comprehensive, AI-powered approach
Idea/Concept
Initial concept development and feasibility assessment
Design & Development
Engineering design, prototyping, and technical development
Risk Management
Comprehensive risk assessment and mitigation strategies
Literature Review
Comprehensive literature search and clinical evidence gathering
DHF/DMR
Design History File and Device Master Record creation
Post Market Compliance
Ongoing compliance monitoring and surveillance
Change Management
Managing design changes and regulatory updates
Idea/Concept
Initial concept development and feasibility assessment
Design & Development
Engineering design, prototyping, and technical development
Risk Management
Comprehensive risk assessment and mitigation strategies
Literature Review
Comprehensive literature search and clinical evidence gathering
DHF/DMR
Design History File and Device Master Record creation
Post Market Compliance
Ongoing compliance monitoring and surveillance
Change Management
Managing design changes and regulatory updates
About Regulify.ai
We’re a MedTech-first technology company redefining product realization. Our mission is to turn years into months by reducing friction, uncertainty, and inefficiencies across the MedTech product lifecycle.
We fuse advanced AI with deep MedTech expertise to help teams accelerate what matters most — delivering transformative technologies to patients with speed and confidence.
Our mission is to bridge the gap between cutting-edge medical technology and regulatory compliance, making it possible for breakthrough devices to reach the market without compromising on quality or safety.
Our Core Competencies
Our Story
Our founding team brings decades of experience around end-to-end MedTech product realization that includes regulatory and compliance development as well as commercialization. We've walked the path from concept to market, and we know where the pitfalls lie.
With a unique blend of:
- Engineering and regulatory know-how,
- A strong foundation in design controls and quality systems,
- And modern AI infrastructure tailored to MedTech
Today, we are helping medical device companies bring their innovations to market faster, with a 98% first-time approval rate and average time savings of 50%+.
Our Approach
Understand Your Vision
We start by deeply understanding your medical device concept and regulatory goals.
Design the Strategy
Create a customized development and regulatory strategy tailored to your device.
Optimize with AI
Leverage our AI tools and expertise to accelerate development and documentation.
Deliver Results
Guide you through regulatory submission and market launch with confidence.
Our Values
Excellence
We maintain the highest standards in everything we do, ensuring regulatory compliance and quality.
Innovation
We continuously innovate to make medical device development faster, more efficient, and more accessible.
Patient Focus
Every decision we make is guided by our commitment to improving patient outcomes and safety.
Your Data is Secure
We understand that medical device development involves sensitive intellectual property. That's why we've built our platform with security, privacy, and data ownership as core principles.
Data Ownership
All templates, files, and outputs are customer-owned and isolated per account. Regulify never shares, sells, or accesses your content without your explicit consent, ensuring your intellectual property remains secure.
Data Privacy
We implement strict privacy controls with customizable anonymization and retention policies. Our AI systems ensure zero data retention with external LLM providers, maintaining complete confidentiality of your sensitive medical device information.
Data Security
Regulify follows enterprise-grade security standards built on AWS infrastructure. While we pursue SOC 2 Type II and HIPAA compliance, our current security framework ensures robust protection through encrypted data transmission, secure cloud storage, and comprehensive access controls.
Security Commitment
While we are actively pursuing SOC 2 Type II and HIPAA compliance certifications, we currently maintain enterprise-grade security standards that ensure your medical device data is protected with the highest levels of security, privacy, and confidentiality throughout your development journey.
Ready to Accelerate Your MedTech Journey?
Connect with our experts to learn how we can fast-track your path to market. Get a free consultation and customized project assessment.
Quick Response Guarantee
We respond to all inquiries within 24 hours and provide detailed project assessments within 48 hours.
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