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

200%+ 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
Bastian Krapinger-RütherMarkus MüllerHasib Samad

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