Your MedTech compliance copilot

Utilize AI to automate your quality and regulatory compliance processes.
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Purpose built for MedTech manufacturers

Our mission: Empowering medical device manufactures to automate compliance processes to launch and operate high-quality products with 10x efficiency. 100% compliant.

Software development according to

IEC 62304

Risk management according to

ISO 14971

Validated according to

ISO 80002-2

Our first product

AI-assisted Post-Market Surveillance automation

Collect

Automated collection of all PMS data in one tool.

Act

Integrated with other QM/RA processes.

Evaluate

Efficient, AI-supported result evaluation.

Report

Automated, MDR compliant documentation.

Flinn provides easy access and fast appraisal, streamlining the process for healthcare professionals.

Three modules to automate your PMS

Automated
Safety Database
surveillance

500%+ productivity increase
Search 15+ databases with 1-click
Audit-ready documentation in seconds

Intelligent
Literature
evaluation

3x faster, AI-driven paper evaluation
40m papers, purchased with 1 click
AI-assisted report writing

AI-driven
Complaint Data
handling

Trend reporting automated
Vigilance cases detected in seconds
Risks continuously monitored
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Automated collection of all PMS data in one tool

Effortlessly gather data from multiple data sources, filtering out irrelevant reports, documents, and posts effectively.  

Efficient, AI-assisted result evaluation

All data can be evaluated for PMS purposes directly in the tool. The evaluation process is fully traceable and AI-supported to increase efficiency.

Automated, MDR compliant documentation

All activities are logged. The whole documentation can be generated with one click in an MDR compliant format.
»Leading manufacturers in: Dental, Endoscopy, Contraception, In-Vitro-Diagnostic… trust in our solution to digitalise their regulatory processes.«

Meet the founders

Explore
Image of Bastian Krapinger-Rüther

Bastian Krapinger-Rüther

Sales & Finance

Image of Markus Müller

Markus Müller

Product, People & Marketing

Image of Hasib Samad

Hasib Samad

Technology & Data

Meet some of our advisors and business angels

Image of Etienne Szivo 

Etienne Szivo

Former Global VP at Siemens Healthineers, and ThermoFisher

Image of Helmut Scherer

Helmut Scherer

CTO at Erbe Elektromedizin

Image of Markus Pöttker

Markus Pöttker

Post-Market Surveillance Leader at SmithNephew

Image of Martin Schödel

Martin Schödel

Former Global QM & Compliance Leader at DentsplySirona, and Dräger

Image of Tibor Zechmeister

Tibor Zechmeister

MDR Expert, and Auditor at SIQ

Discover our unique culture

We are building an exceptional team and culture, as only the best people will be able to create high-quality health products that are accessible to everyone.
Learn more

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