Security & Compliance
CERTIFICATIONS
Purpose built for Medical Device Manufacturers with compliance in mind.
VALIDATED SOFTWARE
Software validation isn't a formality — it's proof that every function works correctly and reproducibly. Flinn delivers the complete documentation to back it up.
WITHOUT VS. WITH FLINN
WITHOUT FLINN
Months of manual validation work
Missing or inconsistent protocols
Audit preparation takes weeks
Documentation scattered across systems
No clear traceability
WITH FLINN
IQ/OQ/PQ docs at the push of a button
Complete traceability matrix
Audit-ready in hours, not weeks
Centralized, versioned documentation
Declarations of conformity always current
FRAMEWORK FOR LEVELLED AI RISK EVALUATION
FLARE is Flinn's practical, risk-based validation framework, built specifically for AI in regulatory affairs. No guesswork. No blind trust. Just a methodical path to confident AI adoption.
STEP 01
Software Risk & Intended Use
STEP 02
Vendor Assessment
STEP 03
Stakeholder Risk Analysis
STEP 04
Required Sample Size
STEP 05
Expert Testing
STEP 06
Clear Paths if It Fails
FLARE is open and evolving.
Built for the real-world challenges QA/RA teams face today — and designed to grow with the regulatory landscape. Read the full 6-part deep-dive series on our blog.
AI GOVERNANCE
Your experts decide. Flinn surfaces information, highlights patterns, and extracts data. The final output is always yours to approve. No customer data is ever used for model training.
Human-in-the-loop
Every AI-generated output is reviewed and approved by a qualified user. No automated actions without confirmation.
Full explainability
Every recommendation shows the basis on which it was made. Sources and decision paths are always traceable.
Zero data spillover
AI can only access the data strictly necessary for one isolated task.
No training on your data
Your data is never used to train any model. All LLMs are frozen per release.
SECURITY ARCHITECTURE
Technical measures that hold up in regulated environments — from encryption and access controls to hosting and sub-processors.
Hosting & Infrastructure
AWS Frankfurt — EU only
Frankfurt (eu-central-1)
Data never leaves the EU
Sub-processor list on request
DPA available at any time
End-to-end encryption of data both in transit and at rest
Full database encryption (AES-256)
Secure connection (HTTPS) is enforced for all application endpoints
Enhanced login security protects against unauthorized access
Role-based access controls ensure data access security
Multi-factor authentication secures infrastructure entry points
Database replication and redundancy
Automated database backups and snapshots
Disaster recovery plan
CUSTOMERS
From documentation to regulatory submission — these companies rely on Flinn every day.
With Flinn’s ongoing search feature, we can stay MDR-compliant while working more efficiently. Their technology is truly at the cutting edge.
Kai Braunstetter
Regulatory Affairs Manager
Flinn is simple, straightforward, and easy to use—even for new users. You don’t need a week of training to get started. It’s intuitive and designed with the user in mind.
Nicholas Coltel
Director of Quality Assurance and Regulatory Affairs
We compared numerous providers, but Flinn convinced us with a unique combination of technical expertise, transparency, and customer focus.
Saskia Mathieu
Head of Clinical Affairs
FAQ
Technical measures that hold up in regulated environments — from encryption and access controls to hosting and sub-processors.
Where is our data stored?
All data is stored exclusively on AWS servers in Frankfurt (eu-central-1). Data is never transferred outside the EU.
Is our data used to train AI models?
No. Your inputs, documents, and outputs are never used for model training. This is contractually guaranteed.
Is Flinn classified as a medical device?
Flinn is a SaaS tool to support regulatory processes. Classification depends on the use case — we're happy to advise.
Who are your sub-processors?
Our full sub-processor list is available on request and updated proactively whenever changes occur.
