Flinn.ai

Trusted by 100+MDR/IVDR MedTechLeaders

Trusted by 100+MDR/IVDR
MedTechLeaders

What Flinn Can Do For You

What Flinn Can
Do For You

Flinn is an AI-driven platform to automate your regulatory and quality processes.

Built for the complexity of MedTech compliance

Built for the complexity of Med-Tech compliance.

Handle low to high risk medical devices.

Manage portfolios of any size, from SMEs to enterprises with thousands of Tech Files.

Manage large, complex portfolios of 5-100 Technical Files.

Ensure full compliance with MDR and IVDR.

Gain back your time, focus, and budget

Gain back your time and focus.

Monitor smarter: Search multiple databases at once.

Faster evaluations: AI-assisted.

Audit-ready reports: With one click.

Increased efficiency: Reduce internal costs.

Meet regulatory requirements stress-free

Post-Market Surveillance Reporting (PMS/PSUR)

Post-Market Clinical/Performance Follow-Up (PMCF/PMPF)

Clinical Evaluation/Performance Reports (CER/CPR)

Flinn Offers Solutions That Work for You

Safety DB Monitoring

Literature Evaluation

Regulatory Monitoring

Complaint Handling

Automate global safety database monitoring with ease, ensuring comprehensive compliance and saving valuable time.

Learn More

Flinn Offers Solutions That Work for You

Automate global safety database monitoring with ease, ensuring comprehensive compliance and saving valuable time.

Learn More

Safety DB Monitoring

Literature Evaluation

Regulatory Monitoring

Complaint Handling

Flinn Offers Solutions That Work for You

Safety DB Monitoring

Literature Evaluation

Regulatory Monitoring

Complaint Handling

Automate global safety database monitoring with ease, ensuring comprehensive compliance and saving valuable time.

Learn More

Features That Maximize Your Efficiency

Features That Maximize
Your Efficiency

Safety DB Monitoring

Literature Evaluation

Regulatory Monitoring

Complaint Handling

15+ Databases Accessible with 1-Click

Real-time Monitoring

1-Click Audit-Readiness

Background De-Duplication Agent

Easily Accessible Market Insights

Safety DB Monitoring

Literature Evaluation

Regulatory Monitoring

Complaint Handling

15+ Databases Accessible with 1-Click

1-Click Audit-Readiness

Real-time Monitoring

Background De-Duplication Agent

Easily Accessible Market Insights

Safety DB Monitoring

Literature Evaluation

Regulatory Monitoring

Complaint Handling

14+ Databases Accessible with 1-Click

Real-time Monitoring

1-Click Audit-Readiness

Automated De-Duplication

Easily Accessible Market Insights

Don't just take our
word for it

“Flinn's safety database monitoring software automated repetitive tasks, freeing our team to focus on more valuable, engaging work.”
Helmut Scherer
Chief Technology Officer
"With Flinn’s ongoing search feature, we can stay MDR-compliant while working more efficiently. Their technology is truly at the cutting edge."
Kai Braunsteffer
Regulatory Affairs Manager
“Flinn is more than just a software provider – they think ahead and develop solutions that truly address the challenges in our industry.”
Saskia Mathieu
Head of Clinical Affairs
"Flinn helps us stay on top of the state of the art by streamlining literature reviews and regulatory tracking with AI-powered insights—saving time and ensuring we stay aligned with the latest standards."
Eduardo Serrano Fernández
Chief Scientific Officer
"With Flinn’s AI-powered solutions and seamless workflow integration, we’ve unlocked new levels of efficiency and insight."

Ben Harder
Head of Clinical Affairs
"Flinn transformed how we manage PMS data. Instead of spending months collecting, sorting, and translating, everything is automated and centralized."
Nicolas Coltel
Director of Quality Assurance and Regulatory Affairs

Don't just take our word for it

“Flinn's safety database monitoring software automated repetitive tasks, freeing our team to focus on more valuable, engaging work.”

Helmut Scherer

Chief Technology Officer

"With Flinn’s ongoing search feature, we can stay MDR-compliant while working more efficiently. Their technology is truly at the cutting edge."

Kai Braunsteffer

Regulatory Affairs Manager

“Flinn is more than just a software provider – they think ahead and develop solutions that truly address the challenges in our industry.”

Saskia Mathieu

Head of Clinical Affairs

"Flinn helps us stay on top of the state of the art by streamlining literature reviews and regulatory tracking with AI-powered insights—saving time and ensuring we stay aligned with the latest standards."

Eduardo Serrano Fernández

Chief Scientific Officer

"With Flinn’s AI-powered solutions and seamless workflow integration, we’ve unlocked new levels of efficiency and insight."

Ben Harder

Head of Clinical Affairs

Director of Quality Assurance and Regulatory Affairs

"Flinn transformed how we manage PMS data. Instead of spending months collecting, sorting, and translating, everything is automated and centralized."

Nicolas Coltel

Director of Quality Assurance and Regulatory Affairs

Choose Flinn with Confidence

Validated Software and Documentation  

We adhere to IEC 62304 and ISO/TR 80002-2 standards, providing full validation documentation that is following ISO 13485, including templates, to ensure compliance and reliability.

Validated Software and Documentation  

We adhere to IEC 62304 and ISO/TR 80002-2 standards, providing full validation documentation that is following ISO 13485, including templates, to ensure compliance and reliability.

Reliable and Certified

Systems    

Flinn ensures 99% uptime with ISO 27001, ISO 14971, and FDA 21 CFR Part 11 compliance, guaranteeing trusted operations.

Reliable and Certified

Systems    

Flinn ensures 99% uptime with ISO 27001, ISO 14971, and FDA 21 CFR Part 11 compliance, guaranteeing trusted operations.

AI and Feature

Excellence

Our AI achieves top-class accuracy rates, with both AI and non-AI features tailored exclusively for the MedTech industry, while ensuring full compliance with the guidelines set by the EU AI Act.

AI and Feature

Excellence

Our AI achieves top-class accuracy rates, with both AI and non-AI features tailored exclusively for the MedTech industry, while ensuring full compliance with the guidelines set by the EU AI Act.

Say Goodbye to
Manual Work and Errors

Unite data, automate processes, and collaborate efficiently.

Book a Demo

Say Goodbye to
Manual Work
and Errors.

Unite data, automate processes, and collaborate efficiently.

Book a Demo

Say Goodbye to
Manual Work and Errors

Unite data, automate processes, and collaborate efficiently.

Book a Demo

Meet our Strategic Advisors

Meet our
Strategic Advisors

Meet our Strategic Advisors

Michael Reitermann
Former CEO of Siemens Healthineers Diagnostics
Katrin Pucknat
Chief Marketing Officer at
ResMed
Markus Pöttker
Global Post-Market Surveillance Leader at Smith&Nephew
Etienne Szivo
Former Global VP at Siemens Healthineers, and ThermoFisher
Michael Schmidt
25+ years of experience as a Quality Management leader in the MedTech field
Helmut Scherer
CTO at Erbe Elektromedizin
Martin Schödel
Former Global QM & Compliance Leader at DentsplySirona, and Dräger

Michael Reitermann
Former CEO of Siemens Healthineers Diagnostics
Katrin Pucknat
Chief Marketing Officer at
ResMed
Markus Pöttker
Global Post-Market Surveillance Leader at Smith&Nephew
Etienne Szivo
Former Global VP at Siemens Healthineers, and ThermoFisher
Michael Schmidt
25+ years of experience as a Quality Management leader in the MedTech field
Helmut Scherer
CTO at Erbe Elektromedizin
Martin Schödel
Former Global QM & Compliance Leader at DentsplySirona, and Dräger

Flinn’s strategic advisors support us as private investors and unpaid mentors.

Known from

Our Strategic Partners

qtec Services GmbH

qtec supports medical device manufacturers throughout the entire product lifecycle—from idea to post-market surveillance. As a trusted partner, they complement our expertise with MDR-compliant support in risk management, clinical evaluation, and regulatory affairs.

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MIRA.Digital GmbH

MIRA digital offers a smart paper purchasing tool for scientific literature. With 20 years of experience supporting global enterprises, MIRA enables Flinn clients to seamlessly access full-text articles team-wide—streamlining evidence collection and reducing manual effort.

Find out more