AI Assisted Post Market Surveillance

70% automated,
100% process compliant

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Compliance,
all simple

We enable medical device manufactures to automate quality and regulatory processes to launch and operate high quality, compliant products efficiently.

Software development according to

IEC 62304

Risk management according to

ISO 14971

Validated according to

ISO 80002-2

End to end PMS automation

Collect

Automated collection of all PMS data in one tool.

Act

Integrated with QMS 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.

What we offer

Incident
database
surveillance

300%+ productivity increase
10+ global databases
32M+ reports

Clinical
literature
evaluation

3x faster Ai supported appraisal
100% traceable workflow
1-click audit ready documentation

More to
come

Complaint data processing
Cybersecurity surveillance
QM process integrations
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Automated collection of all PMS data in 1 tool

Effortlessly gather and analyse data from multiple databases while simplifying data management and facilitating informed decision-making.

Efficient, AI-supported 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 by one click in a 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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