Pruva AI
Your Bridge Between Innovation, Compliance, and Market Access
In the complex world of HealthTech, getting your innovation to market safely and efficiently is the ultimate challenge. Healthcare Innovation provides the solution through PRUVA AI, our dedicated platform for scientific, regulatory, and commercial validation.
PRUVA AI acts as a bridge between science, regulation, and the market. We leverage a powerful combination of human expertise and artificial intelligence to help startups and established companies structure, validate, and ensure their products comply with the highest international standards.
We specialize in supporting solutions across HealthTech, MedTech, cosmetics, and nutrition.
What We Do Your End-to-End Validation Partner
PRUVA AI handles our core consulting and validation services, guiding you from concept to commercialization.
1. Regulatory, Quality & Compliance Consulting
Regulatory Diagnostics
We assess your product’s compliance with Tunisian and European frameworks (including INNORPI, CNDP, MDR).
ISO 13485 & MDR Expertise
Our network includes experts specializing in ISO 13485 and MDR standards.
ISO 13485 Design & Development
PRUVA AI is currently undergoing ISO 13485 certification as a dedicated unit for the design and development of medical devices. We are uniquely positioned to manage your quality assurance and design (C&D) processes.
Data & Ethics
We provide guidance on cybersecurity, data protection (in line with CNDP), and ethical considerations.
2. Scientific & Clinical Validation
We provide the scientific proof your innovation needs by coordinating robust testing and trials.
Test Coordination
We manage tests and trials in collaboration with a network of accredited laboratories and experts.
Supported Products
Our validation services cover medical devices, cosmetics, and food supplements.
Dynamic Protocols
Our platform provides dynamic recommendations for test protocols based on your product’s specific profile.
Expert Matching
We connect you with qualified scientific and clinical experts from our extensive network.
3. Commercial & Market Access Strategy
A compliant product needs a clear path to market. We provide the market intelligence to build your strategy.
Market Studies
We conduct in-depth market research and competitive analysis for the Tunisian and Euro-Mediterranean markets.
Market Access
We validate your product’s potential for adaptation and integration into local distribution chains
Positioning Analysis
We support your market access strategy through detailed sectoral studies and positioning analyses.
Our Expertise: Powered by AI and Human Intelligence
Our strength lies in our network. PRUVA AI brings together over 40 experts from academic, hospital, and industrial backgrounds.
Our expert network covers:
- Clinical Evaluation and Health Technology Assessment (HTA)
- Quality Standards (ISO 13485, MDR, IEC 62304)
- Biostatistics and Clinical Study Design
- Artificial Intelligence, Cybersecurity, and Data Protection
- Ethics, Compliance, and Scientific Communication
This network is supported by the partners of the Healthcare Innovation Cluster, including leading pharmaceutical companies (Opalia Recordati, Roche, Novo Nordisk), academic institutions (Faculty of Pharmacy of Monastir, Institut Pasteur de Tunis), and international innovation structures (Marseille Technopole, France Biotech5.
Who We Serve
PRUVA AI is designed to support the entire health innovation ecosystem:
Our Vision
Our mission is to position Tunisia as a Euro-Mediterranean hub for scientific and regulatory validation. We are committed to accelerating the market launch of innovative, safe, and sustainable health solutions.
Ready to validate your innovation?
Contact us today to learn how PRUVA AI can secure your product’s journey from concept to market.