AI-enabled
Safety Database Monitoring
Literature Evaluation
Regulatory Monitoring
Complaint Handling
Safety Database Monitoring
Tailored to MDR / IVDR requirements
AI-enabled
Safety Database Monitoring
Literature Evaluation
Regulatory Monitoring
Complaint Data Handling
Safety Database Monitoring
Tailored to MDR / IVDR requirements
AI-enabled
Safety DB Monitoring
Literature Evaluation
Regulatory Monitoring
Complaint Handling
Safety DB
Monitoring
Tailored to MDR / IVDR requirements
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.
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.
Ensure full compliance with MDR and IVDR.
Ensure full compliance with MDR and IVDR.
Gain back your time, focus, and budget
Gain back your time and focus.
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)
Clinical Evaluation/Performance Reports (CER/CPR)
Flinn Offers Solutions That Work for You
Automate global safety database monitoring with ease, ensuring comprehensive compliance and saving valuable time.
Flinn Offers Solutions
That Work for You
Automate global safety database monitoring with ease, ensuring comprehensive compliance and saving valuable time.
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.
Features That Maximize Your Efficiency
Features That Maximize Your Efficiency
Features That Maximize
Your Efficiency
Safety DB Monitoring
Literature Evaluation
Regulatory Monitoring
Complaint Handling
Real-time Monitoring
1-Click Audit-Readiness
Automated De-Duplication
Easily Accessible Market Insights
Safety DB Monitoring
Literature Evaluation
Regulatory Monitoring
Complaint Handling
1-Click Audit-Readiness
Real-time Monitoring
Automated De-Duplication
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
"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'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 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 AI-powered solutions and seamless workflow integration, we’ve unlocked new levels of efficiency and insight."
Ben Harder — Head of Clinical Affairs
"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 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 AI-powered solutions and seamless workflow integration, we’ve unlocked new levels of efficiency and insight."
Ben Harder — Head of Clinical Affairs
"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 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
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.
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.
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.
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.
Say Goodbye to
Manual Work
and Errors.
Unite data, automate processes, and collaborate efficiently.
Say Goodbye to
Manual Work and Errors
Unite data, automate processes, and collaborate efficiently.
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
ResMedMarkus 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
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.
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.
Common Questions. Great Answers.
Common Questions.
Great Answers.
Common Questions. Great Answers.
What regulatory frameworks does Flinn support?
Does the Flinn software comply with standards relevant for Medtech?
Is the data stored securely and GDPR compliant?
Does Flinn’s software comply with the EU AI Act?
Do I need to install or host Flinn’s software?
Is the Flinn software validated?
Is the report generated by the Flinn software accepted by notified bodies?
Do I get the same search results with Flinn as I would in original databases?
What does the onboarding process for Flinn’s software typically involve?
How long does it take to implement Flinn’s software in our existing workflows?
What regulatory frameworks does Flinn support?
Does the Flinn software comply with standards relevant for Medtech?
Is the data stored securely and GDPR compliant?
Does Flinn’s software comply with the EU AI Act?
Do I need to install or host Flinn’s software?
Is the Flinn software validated?
Is the report generated by the Flinn software accepted by notified bodies?
Do I get the same search results with Flinn as I would in original databases?
What does the onboarding process for Flinn’s software typically involve?
How long does it take to implement Flinn’s software in our existing workflows?
What regulatory frameworks does Flinn support?
Does the Flinn software comply with standards relevant for Medtech?
Is the data stored securely and GDPR compliant?
Does Flinn’s software comply with the EU AI Act?
Do I need to install or host Flinn’s software?
Is the Flinn software validated?
Is the report generated by the Flinn software accepted by notified bodies?
Do I get the same search results with Flinn as I would in original databases?
What does the onboarding process for Flinn’s software typically involve?
How long does it take to implement Flinn’s software in our existing workflows?
Let us show you
Let our experts walk you through Flinn’s software, showcasing the features that matter most for your use case.
Let us show you
Let our experts walk you through Flinn’s software, showcasing the features that matter most for your use case.
Let us show you
Let our experts walk you through Flinn’s software, showcasing the features that matter most for your use case.
© 2025, 1BillionLives GmbH, All Rights Reserved
© 2025, 1BillionLives GmbH,
All Rights Reserved
© 2025, 1BillionLives GmbH,
All Rights Reserved