Welcome to AI HealthTech Guide, where regulatory expertise meets creative thinking, enabling our clients to navigate compliance requirements while accelerating their innovation journey. This balanced approach helps transform regulatory challenges into opportunities for market leadership.
At the intersection of AI and medical technology, we specialize in transforming regulatory requirements into strategic business advantages. Our extensive expertise in EU MDR and the emerging AI Act helps European healthcare innovators develop compliant yet innovative solutions.
We view compliance as an enabler, not a barrier. By developing streamlined pathways through complex regulatory frameworks, we accelerate our clients’ go-to-market journey while ensuring robust alignment with European standards.
Having transitioned from industry role in both small and large companies to founding my consultancy, I bring unique insights into the challenges faced by both established medical device manufacturers and AI-driven startups. My approach emphasizes pragmatic solutions that turn regulatory complexity into competitive advantage.
Mission
Our mission is to empower healthcare innovators and manufacturers to bring life-changing medical devices to market efficiently, ethically, and safely.
We strive to be the trusted partner that enables our clients to navigate the intricate landscape of regulatory compliance, quality assurance, and clinical validation.
By offering comprehensive consultancy services tailored to their unique needs, we aim to foster innovation, improve patient outcomes, and enhance the accessibility of cutting-edge health technologies worldwide.
Vision
Our vision is to become a global leader in medical device consultancy, renowned for our unwavering commitment to excellence, integrity, and client satisfaction.
We envision a future where every healthcare innovator has the support and guidance they need to realize their vision and make a profound impact on the world.
Through strategic partnerships, continuous innovation, and a dedication to the highest standards of professionalism, we aspire to shape the future of healthcare by facilitating the development and deployment of innovative medical devices that transform lives and advance human well-being.
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AI Act navigation
Working at the intersection of AI and medical technology, we are strategic consultants helping healthcare innovators navigate complex regulatory landscapes..
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EU MDR experts
With deep expertise in EU MDR and the emerging EU AI Act, we partner with companies to ensure their AI-powered medical solutions meet stringent compliance requirements while maintaining innovation velocity.
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Product launches
Our solution-focused methodology transforms regulatory obligations into opportunities for product excellence and market differentiation.
Area of Expertise
01
Compliance
We will work with you to create EU MDR and AI Act compliance strategy.
Our regulatory affairs consulting service helps AI-driven healthcare companies achieve swift market access while maintaining full compliance.
02
Person Responsible for Regulatory Compliance (PRRC)
Ensure compliance with PRRC requirements seamlessly. Our team will guide you through the process, helping you meet all regulatory obligations. Need additional support? You can outsource the PRRC role to us and rely on our expertise to maintain full compliance with the EU MDR and AI Act.
03
Technical documentation
We will work with you to create and develop comprehensive technical documentation and prepare regulatory submissions aligned with the EU MDR and AI Act requirements, using a lean and efficient approach to ensure compliance with minimal complexity.
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Regulatory intelligence and impact analysis
We transform complex requirements into clear action plans, enabling you to focus on innovation while ensuring regulatory excellence. Our hands-on approach combines deep regulatory knowledge with practical implementation, delivering measurable results and accelerating your path to market.
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European Representative (EC REP)
Our EC REP service offers comprehensive support to manufacturers outside the EU, ensuring compliance with regulatory requirements and facilitating market access.
Focus on your core business activities while we handle regulatory matters on your behalf, providing peace of mind and assurance of compliance.
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Quality Management System optimization
We will work with you to streamline your QMS with a lean, efficient approach tailored to meet the EU MDR and AI Act. We focus on integrating essential requirements while minimizing complexity, ensuring compliance and scalability.
Our Amazing Team
Senior Consultant
Anna
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Senior Consultant
Maria
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Senior Consultant
Peter
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