ISO 13485 compliance made simple with Daiki’s eQMS and AI Assistant
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.
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 assistant provides immediate answers to your compliance questions, saving you research time and accelerating your product launch.
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.
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.
The Daiki AI Assistant 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
Daiki was built by a multidisciplinary team of experts. We combine legal, ethical, design, and machine learning expertise to enable responsible AI development.
Our goal is to not just ensure your compliance with ISO 13485 but to also enhance your development process, QMS, and operational efficiency using AI technologies.
Opt for trusted and regulatory-compliant tech stacks, such as Daiki’s Secure Private Large Language Models (LLMs) and Retrieval Augmented Generation (RAG) system.
Daiki was built by a multidisciplinary team of experts. We combine legal, ethical, design, and machine learning expertise to enable responsible AI development.
Our goal is to not just ensure your compliance with ISO 13485 but to also enhance your development process, QMS, and operational efficiency using AI technologies.
Opt for trusted and regulatory-compliant tech stacks, such as Daiki’s Secure Private Large Language Models (LLMs) and Retrieval Augmented Generation (RAG) system.
Get in touch to start your free trial.
Set up the processes for MDR compliance with pre-filled documents quickly. Start your step-by-step journey towards compliance at scale.
€1119 / month
€1399 / month
Experience the eQMS without limits, including AI integrations and a dedicated compliance success manager.
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Find answers to frequently asked questions about Daiki.
MDR compliance refers to the adherence to the European Union’s Medical Device Regulation (EU MDR 2017/745), which sets stringent standards for the design, production, and marketing of medical devices in the EU. This regulation ensures that medical devices meet high safety and performance criteria before they can be sold or put into service in the European market.
ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. It supports the design, development, production, and delivery of medical devices that consistently meet regulatory and customer requirements.
ISO 13485 certification demonstrates a commitment to quality and regulatory compliance, crucial for market trust and credibility. For ML developers, it means working within a framework that promotes consistency, reliability, and safety in device development, ultimately facilitating regulatory approvals.
While ISO 13485 certification is not explicitly required for MDR compliance, it provides a structured approach to meeting many of the quality management and regulatory requirements of the MDR. Therefore, it’s highly beneficial and often seen as a de facto requirement for demonstrating compliance.
MDR places specific emphasis on clinical evaluation, risk management, and post-market surveillance of medical devices, including those powered by AI and ML. Developers must demonstrate that their AI algorithms are reliable, can be reproduced under similar conditions, and include measures for data protection and patient safety.
The frequency of re-certification depends on the device’s classification and any significant changes made to the device or its software, including updates to the AI algorithms. Manufacturers must assess whether modifications could affect the device’s safety or performance and if a new conformity assessment is required.
The platform minimizes consulting costs by offering AI-guided insights, automates compliance processes, and provides efficient documentation management, ultimately reducing both time and financial investments needed for compliance.
Yes. You can submit compliance results directly to international bodies through Daiki’s integrated interface, simplifying external audits and helping your team achieve peace of mind.
The system is designed to continuously learn and update its database with the latest regulatory changes, ensuring that your compliance efforts are always current.
Daiki is committed to using trusted and regulatory-compliant technology stacks, ensuring the highest standards of data security and privacy.
No matter how much experience you have with AI and quality management: Daiki offers you the right infrastructure to implement your use cases.
Sign up today for a demo or apply to our pilot program
