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Achieve Zero Non-Conformities through AI-Powered Compliance Monitoring
We help Legal Manufacturers meet their compliance obligations across a device's design, production, market release, and post-market operation—automatically and without sacrificing innovation.
The Reality of Medical Compliance
"At our last unexpected audit, we received 2 major non-conformities and 6 minor. because we were missing some records. This set us back 8 months in our development cycle."
- CTO, Medical Device Company
"We thought we were compliant until the auditor found we deviated from the process. The remediation cost us €45,000 and delayed our product launch by 4 months."
- Quality Manager, Startup
"One overlooked procedure requirement led to a certificate suspension. We lost access to our key European markets for 6 months while we fixed everything."
- Regulatory Affairs Director
The Hidden Gap in Your Compliance Readiness
Even with dedicated teams, overlooked areas can compromise your compliance readiness.
Translating Standards into QMS is Complex
Translating medical standards & regulations into a Quality Management System correctly is challenging even for compliance professionals, leading to gaps in implementation.
Engineer Knowledge Gaps
Compliance is not always a core competency for engineers, leading to inadvertent non-conformities during the device's life cycle.
Additionally, a QMS spans an enormous volume of documents and records - no human could possibly oversee everything comprehensively.
Non-Conformities: The Costs of Being Non-Compliant
Financial Impact
It easily costs €20+k to resolve a single Non-Conformity.
It easily costs €10+k to prepare for a single audit.
Delay to Market
Products face 3 to 6 months of delay due to a single, unexpected non-conformity requiring mandatory CAPA validation.
Loss of Market Access / Trust
Non-conformities can lead to loss of trust, certificate suspension and the (temporary) loss of access to critical target markets.
Qualora AI: 100% Digital Verification for True 24/7 Compliance
Regulations
Quality Procedure / SOP
Work Instructions & Templates
Records
Reduce Cost & Delay
Minimize expenses and avoid market delays by catching non-conformities before they impact your operations.
Always Audit Ready
Ensure continuous compliance and readiness for any audit with automated, real-time verification of all documentation.
Improved Customer Trust & AI-Monitor Certificate
Build stronger customer trust and validate your commitment to quality with an official AI-Monitor compliance certificate.
Secure & Seamless Deployment
Qualora AI is engineered for secure integration into your existing infrastructure, respecting your data sovereignty and operational workflows.
Private Cloud Ready
Deploy Qualora directly within your private cloud or on-premise infrastructure, maintaining complete control over your environment.
Data Stays Yours
Your sensitive compliance data never leaves your environment. We guarantee no transmission to external third-party providers.
Integrates with Your Tools
Seamlessly connect with your existing document management systems like Jira, Confluence, and SharePoint for a unified compliance workflow.
The Team behind Qualora
Andre Bruls
25+ years in Medical Device Industry
Q&R manager / Final Reviewer & Certification Decision Maker
Theo Gransier
25+ years in Medical Device Industry
Internal / Notified Body Lead Auditor
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