Your Trusted Partner in Navigating AI Act & MDR Compliance
Welcome to AI Health Tech Guide
In today’s fast-paced health and med tech industries, innovation meets regulation at every step. Whether you’re building AI-driven diagnostics, wearable devices, or cutting-edge medical solutions, understanding the EU Artificial Intelligence Act (AI Act) and the Medical Device Regulation (MDR) is crucial to your success.
At AI Health Tech Guide, we simplify complexity. Our platform is designed to give you the insights, tools, and guidance you need to bring compliant, future-ready innovations to market confidently.
✓ For HealthTech Companies
✓For AI Entrepreneurs and startups
✓ For MedTech companies
Why compliance matters?
Navigating regulations isn’t just about avoiding penalties—it’s about ensuring safety, trust, and marketability.
- Ensures Patient Safety: Compliance guarantees that products meet stringent safety and quality standards, protecting end users.
- Builds Trust and Credibility: Demonstrating adherence to regulations fosters confidence among patients, healthcare providers, and investors.
- Facilitates Market Access: Regulatory compliance is essential for obtaining CE marking and accessing EU and global markets.
- Minimizes Legal and Financial Risks: Reduces the likelihood of penalties, recalls, or reputational damage due to non-compliance.
- Encourages Innovation: Clear regulatory frameworks provide a structured path for integrating advanced technologies like AI.
- Future-Proofs the Business: Staying compliant with evolving regulations ensures long-term sustainability and competitiveness.
Need training?
First Glimpse of Key Regulations
Explore simplified overviews of the AI Act and MDR to understand their impact on your business.
Comprehensive explanations on conformity assessments, clinical evaluations, and post-market surveillance specific to medical devices.
Need templates?
Practical Compliance Tools
Ready-to-use templates and checklists for creating compliant technical documentation, including risk management plans, QMS procedures, forms and other requirements. Step-by-step resources to help classify your AI system, identify risk levels, and prepare technical documentation.
Need deeper support?
Tailored Consultancy Services
Our compliance experts are here to guide you step-by-step, helping you design strategies that align with your goals.
Expert tips to take the guesswork out of regulatory requirements such as EU MDR and EU AI Act.
We can help you
✓ Stay Ahead of the Curve
✓ Simplify Complex Rules
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Regulatory intelligence
Stay informed on regulatory changes, deadlines, and best practices through news and insightful articles tailored to Healthtech and Medtech innovators.
Solution oriented
Our dedicated team is always available to assist you.
Innovation enablers
Stay focused on innovation while we help you with regulation.
Cross-Regulation Integration
Practical advice on overlapping requirements between the AI Act and MDR, ensuring cohesive and efficient compliance strategies.
Who Is It For?
AI HealthTech Guide serves startups, established companies, and regulatory professionals working at the intersection of AI and healthcare, offering them the clarity and resources needed to bring innovative, compliant solutions to market.
Top Features
✓ AI Act Insights
✓ EU MDR Guidance
✓ Customizable Templates
Service designed for every need.
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Regulatory Compliance Consulting
Comprehensive regulatory solutions for businesses tailored to your needs.
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Solution oriented expertise
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Advice on specific topic
✓ PRRC support
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Priority and flexible support
Training and Education Programs:
Offering training for staff on EU MDR, EU AI Act and specifically tailored trainings for your needs.
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Online training
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Onsite training
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Dedicated support throughout your journey
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Unlimited customer inquiries
QMS SOP development and Implementation:
Help in developing and implementing an Quality Management System (QMS) to meet EU regulations.
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Gap Assessment
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Risk management
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Customised procedures
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Internal audits
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Support for external NB audits
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Supplier audits
Technical Documentation Support
Assistance in creating and updating technical documentation needed for compliance with the EU regulations
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Creation, review or advice depending on the need
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Preparation for NB reviews
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EC REP service (if applicable)
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Access to exclusive industry expertise
What our customers say
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I’m truly grateful for the exceptional support I received from AI HealthTech guide.
Their expertise, dedication, and professionalism made a significant difference in my case.
Highly recommended.
Alice Smith
HealthTech AI Company
Stay ahead with the latest regulatory news, insights, and expert knowledge.
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What is EU MDR?
The European Union Medical Device Regulation (EU MDR) is a comprehensive framework governing the safety, quality, and performance of medical devices within the European Union.
What is EU AI ACT?
The European Union Artificial Intelligence (EU AI) Act is the world’s first comprehensive legal framework regulating AI, aimed at ensuring the safe and ethical development, deployment, and use of AI systems in the European Union.
Who is impacted by EU AI Act?
The EU AI Act, that came into force on 1st of August , 2024, impacts a range of stakeholders, including AI developers and providers who must adhere to specific regulations based on the risk level of their systems. Additionally, businesses and organizations utilizing AI technologies will need to comply with the Act’s requirements to ensure safety, transparency, and accountability in their AI applications.
What is definition of a medical device?
‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease…
How is AI defined in AI ACT?
‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.
How are medical devices affected?
The EU AI Act significantly impacts medical devices by classifying AI-enabled systems as high-risk, necessitating compliance with stringent safety and transparency requirements. Manufacturers must ensure that their AI systems meet both the AI Act and existing EU MDR, which involve extensive documentation and Notified body assessments to demonstrate conformity (for higher risk device class).
Questions?
Unable to locate the answers or services you need? Allow us the opportunity to assist you; let’s have a conversation.
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