Get ready for QLAP
QLAP is DYI compliance platform designed to help medical device manufacturers, using LLM, to meet complex EU regulations, especially EU MDR (Medical Device Regulation) and EU IVDR (In Vitro Diagnostic Regulation). It automates regulatory audits and technical documentation compliance by integrating with existing eQMS (electronic Quality Management Systems) and workflows, replacing manual labour, errors, and reliance on external experts.
Key Features of QLAP
- Replaces regulatory consultants
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Automation of risk management, clinical evaluation & regulatory gap analysis using AI trained on specific datasets related to MDR and IVDR.
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High data security with military-grade encryption and strict data segregation.
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AI models tailored to your company´s regulatory needs.
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Compliance with the EU AI Act regarding dataset validation, bias detection, and anonymization.
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API-first integration for seamless connection with core company systems.
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Multi-tier subscription revenue model for startups, teams, and enterprises.
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Global market focus on the growing MedTech and biotech sectors.
- ISO 27001 & 42001 Certified
QLAP aims to reduce compliance costs, increase accuracy, and improve efficiency for medical device companies navigating stringent EU regulatory requirements.