Bringing ease
to MedTech
AI-powered regulatory solutions that transform complex medical device compliance into streamlined, market-ready innovations.
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 Services
From initial concept to market launch and beyond, we provide end-to-end support for all your medical device development needs.
Product Development
Engineering support from concept to market-ready devices.
Our comprehensive product development services cover the entire lifecycle of medical device creation. From initial concept validation and feasibility studies to detailed engineering design, prototyping, and clinical testing, we ensure your device meets the highest standards of safety and efficacy.
Need a Custom Solution?
Every medical device is unique. We tailor our services 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.
Execute 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.
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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