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Achieve and Maintain MDR Compliance with Ease

ISO 13485 compliance made simple with Daiki’s eQMS and AI Copilot

Developed by more than 30+ experts from various disciplines

Ready to transform your compliance journey with the power of AI?

At Daiki, we understand the challenges that medical device manufacturers face when striving for ISO 13485 compliance. The landscape of medical device regulation is complex and constantly evolving, making compliance a moving target. However, you don’t have to face this challenge alone.

Introducing Daiki, your AI-assisted partner designed to streamline and simplify your path to achieving and maintaining ISO 13485 certification.

Simplify Certification, Maximize Efficiency

Navigate Regulations with Ease

Step-by-Step ISO 13485 Guidance

Daiki’s interactive platform guides you through medical device compliance step-by-step, making complex regulations simple to understand, regardless of your expertise.

Daiki’s dynamic knowledge base and AI Copilot provides immediate answers to your compliance questions, saving you research time and accelerating your product launch.

Streamline & Automate Compliance

Reduce Costs, Maximize Efficiency

Daiki’s AI insights guide your compliance journey, minimizing consulting costs and ensuring cost-effectiveness.

Daiki’s intelligent system learns and keeps you informed about the latest regulatory changes for medical devices, ensuring you’re always compliant.

Daiki assesses training needs, tailors questionnaires, and generates records automatically. Streamline internal audits and technical documentation creation.

Simplify Documentation & Audit Submission

Effortless Documentation Management

Generate, organize, and manage essential MDR compliance documents with Daiki’s AI assistance. Ensure critical information is easily accessible and always up-to-date.

Submit compliance results directly to international bodies through Daiki’s integrated interface. Simplify external audits and achieve peace of mind.

Helping clients with compliance and beyond

Biotech startup

University Hospital of Basel

Your fast track to ISO 13485 compliance

The Daiki Copilot system addresses all your queries regarding the specific ISO standard, provides templates, and assists in automating documentation and training processes

Electronic Quality Management System (eQMS) for Medical Device (MDR)-compliant document and record control

Simplify the audit process and improve your preparation by implementing a structured audit plan. Leverage the various available interfaces to facilitate the audit submission

Integrated versioning, review, and approval processes, along with private team communication through document-specific comments

Why choose Daiki for MDR Compliance?

Certified Excellence

As an ISO 13485 certified company, we not only talk the talk but walk the walk. We help you apply the same rigorous standards to your operations, ensuring you receive tried and tested compliance solutions.

Responsible AI Leader

Daiki was built by a multidisciplinary team of experts. We combine legal, ethical, design, and machine learning expertise to enable responsible AI development.

Beyond Compliance

Our goal is to not just ensure your compliance with ISO 13485 but to also enhance your product development process, quality management systems, and overall operational efficiency using AI technologies.

Access to AI Tech

Opt for trusted and regulatory-compliant tech stacks, such as Daiki’s Secure Private Large Language Models (LLMs) and Retrieval Augmented Generation (RAG) system.

Need help with AI development?
Apply for our AI Pilot Program

Daiki helps organizations develop and implement successful AI projects. Apply to our pilot program to get started today.

Want to stay ahead of the compliance curve?

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Ready to simplify your ISO 13485 compliance journey?

Contact Daiki today for a consultation and demo. Let our experts help you navigate the complexities of compliance, leaving you free to focus on innovating and growing your business.

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