Automate Your
Regulatory Strategy
The Problem
Too much busywork, not
enough innovation
Endless Manual Work
Re-entering data across dozens of forms.
Fragmented Tools
Juggling PDFs, Excel, and conflicting emails.
Opaque Requirements
Searching for product codes is error-prone.
Endless Manual Work
Re-entering data across dozens of forms.
Fragmented Tools
Juggling PDFs, Excel, and conflicting emails.
Opaque Requirements
Searching for product codes is error-prone.
The Solution
From weeks of manual work to
minutes of automation
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Visualize regulatory landscape
Visualize data, requirements, and compliance metrics easily. Integrate with official FDA, EU MDR, and global databases.
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Automated submission guidelines
Instantly apply regulatory rules, formatting, and required standards so every document is always submission-ready.
Export for Submission
Export your strategy reports and eSTAR templates straight to submission formats.
Customizability
Full control over strategy layouts and visuals without breaking regulatory rules.
Real-time collaboration
Collaborate with your regulatory affairs team. Share drafts and manage permissions.
Enterprise security
Your proprietary medical data stays private, protected by enterprise-grade security.
How It Works
Compliance automated in
three simple steps
Interactive Assessment
Complete our adaptive 35-question wizard. Our system gathers clinical and technical data to build your device's unique profile.
Automated Analysis
Our AI engine cross-references your data with FDA and EU MDR databases to identify the precise regulatory path and product codes.
Instant Strategy Kit
Download your complete strategy report, predicate mappings, and pre-filled eSTAR templates—ready for submission.
Testimonials
Trusted by regulatory
experts worldwide
"Qualicom AI reduced our 510(k) preparation time by 65%. The automated predicate mapping is a game-changer."
Dr. Sarah Chen
@sarah_md
"Finally, a tool that understands EU MDR requirements. The gap analysis reports are precise and actionable."
Michael Ross
@mross_regulatory
"The wizard-based approach made our complex device classification simple. Highly recommended for startups."
Elena Rodriguez
@elenar_tech
"Qualicom AI reduced our 510(k) preparation time by 65%. The automated predicate mapping is a game-changer."
Dr. Sarah Chen
@sarah_md
"Finally, a tool that understands EU MDR requirements. The gap analysis reports are precise and actionable."
Michael Ross
@mross_regulatory
"The wizard-based approach made our complex device classification simple. Highly recommended for startups."
Elena Rodriguez
@elenar_tech
"Qualicom AI reduced our 510(k) preparation time by 65%. The automated predicate mapping is a game-changer."
Dr. Sarah Chen
@sarah_md
"Finally, a tool that understands EU MDR requirements. The gap analysis reports are precise and actionable."
Michael Ross
@mross_regulatory
"The wizard-based approach made our complex device classification simple. Highly recommended for startups."
Elena Rodriguez
@elenar_tech
"Qualicom AI reduced our 510(k) preparation time by 65%. The automated predicate mapping is a game-changer."
Dr. Sarah Chen
@sarah_md
"Finally, a tool that understands EU MDR requirements. The gap analysis reports are precise and actionable."
Michael Ross
@mross_regulatory
"The wizard-based approach made our complex device classification simple. Highly recommended for startups."
Elena Rodriguez
@elenar_tech
"Building a QMS used to take months. With Qualicom, we had our core structure ready in days."
James Wilson
@jwilson_qa
"The eSTAR template auto-fill feature saved us at least 150 hours of manual data entry."
Linda Park
@lpark_med
"A must-have for any medtech company looking to accelerate their time-to-market. Exceptional value."
David Smith
@dsmith_ops
"Building a QMS used to take months. With Qualicom, we had our core structure ready in days."
James Wilson
@jwilson_qa
"The eSTAR template auto-fill feature saved us at least 150 hours of manual data entry."
Linda Park
@lpark_med
"A must-have for any medtech company looking to accelerate their time-to-market. Exceptional value."
David Smith
@dsmith_ops
"Building a QMS used to take months. With Qualicom, we had our core structure ready in days."
James Wilson
@jwilson_qa
"The eSTAR template auto-fill feature saved us at least 150 hours of manual data entry."
Linda Park
@lpark_med
"A must-have for any medtech company looking to accelerate their time-to-market. Exceptional value."
David Smith
@dsmith_ops
"Building a QMS used to take months. With Qualicom, we had our core structure ready in days."
James Wilson
@jwilson_qa
"The eSTAR template auto-fill feature saved us at least 150 hours of manual data entry."
Linda Park
@lpark_med
"A must-have for any medtech company looking to accelerate their time-to-market. Exceptional value."
David Smith
@dsmith_ops
Our Plans
Flexible Pricing for
Every Stage
FAQs
Everything you
need to know
Ready to streamline your regulatory journey?
Join hundreds of medical device manufacturers who trust Qualicom AI to generate their FDA eSTAR and EU MDR submissions 10x faster.
Get Started Now