Explore Our Knowledge Areas
Navigate the complex landscape of EU MDR 2017/745 and IVDR 2017/746 with our expert-led knowledge base.
Legislation
Access the core regulatory frameworks governing medical devices in the EU, including the latest MDR and IVDR texts.
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Technical Documentation
Comprehensive guidelines and templates for Annex II and Annex III technical files to ensure compliance with GSPR.
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Quality Management System
Guidance on implementing and maintaining a QMS compliant with ISO 13485 and Article 10 of the Regulations.
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Medical Device Regulatory Excellence
Welcome to MDR Academy, the premier destination for professionals navigating the intricate world of European medical device regulations. Our platform offers strategically curated intelligence to ensure your products meet the highest standards of safety and clinical performance.
Master EU MDR & IVDR Compliance
Whether you are preparing a technical file for a Class III implantable device or establishing a QMS for a software-as-a-medical-device (SaMD), our resources provide the clarity you need:
- Regulatory Legislation: Access consolidated versions of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
- Technical Documentation: Step-by-step guides for Annex II and III, including GSPR and benefit-risk analysis templates.
- Quality Management (QMS): Expert insights on ISO 13485 implementation and Article 10 compliance.
- Clinical Evaluation: Detailed frameworks for clinical evaluation plans (CEP) and reports (CER) to secure clinical evidence.
Why Choose MDR Academy?
Our platform combines deep regulatory expertise with advanced AI-powered assistant to help you find answers across thousands of pages of legislative text in seconds. Stay ahead of the curve with our continuous updates on MDCG guidance documents and harmonized standards.