Automate Your
Regulatory Strategy
Qualicom AI uses verified medical data and adaptive intelligence to generate comprehensive compliance packages in minutes, not months.
- Verified medical data
- Adaptive intelligence
- Compliance in minutes
Too much busywork, not enough innovation
Manual processes, disconnected tools, and unclear requirements are silently killing productivity.
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.
From weeks of manual work to minutes of automation
Qualicom AI turns complex regulatory workflows into structured, ready-to-use compliance outputs.
Automatically pulls from official FDA, EU MDR, and Health Canada references — no more manual lookups or outdated spreadsheets.
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Compliance automated in three simple steps
We've distilled years of regulatory expertise into a streamlined, AI-driven workflow that takes you from device concept to submission readiness.
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.
Trusted by regulatory experts worldwide
See how Qualicom AI is helping medical technology companies streamline their path to global compliance.
"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
Flexible Pricing for Every Stage
Select a plan tailored to your regulatory needs — from early product development to full compliance and market launch.
Frequently asked
questions
Everything you need to know about Qualicom AI, eSTAR submissions, and our regulatory strategy wizard. Can't find the answer you're looking for?
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