Courses

Welcome to MDR Consultants Inc. – Your Premier Provider of EU MDR & FDA Training Programs

Are you looking to gain a comprehensive understanding of the EU MDR (2017/745) and FDA regulations, along with how to implement them? Our expertly designed courses, including EU MDR 101, EU MDR 201, and FDA 201, are meticulously crafted to equip you with the expertise needed for compliance.

Meet Our Expert Trainers

At MDR Consultants, our team of trainers are not only experts in their field, but also have real-world experience working in leading Quality Assurance/Regulatory Affairs (QA/RA) positions for industry members, as Lead Auditors and Certified Trainers for Notified Bodies, and as consultants to the medical device industry. With a track record of guiding medical device companies from ideation to market release, our trainers bring unparalleled expertise in integrating QA/RA principles throughout the design and development process. This unique combination of skills and experience enables us to provide you with the best possible training experience, grounded in practical insights and industry best practices.

EU MDR 101 & EU MDR 201 Courses – Master the EU MDR Regulation

Are you looking to gain a comprehensive understanding of the EU MDR (2017/745) regulation and how to implement it? Our expertly designed courses are tailored to meet the needs of both newcomers and industry professionals.

EU MDR 101 – The Fundamentals

Our comprehensive EU MDR 101 course is the ideal way to master the ins and outs of the EU MDR regulation. Whether you’re new to the world of medical device regulations or looking to broaden your knowledge, this course is an essential starting point. Our expertly designed curriculum delves into the EU regulatory framework, the classification system for medical devices, the regulatory requirements for devices, the critical role of Notified Bodies, and much more. By the end of the course, you’ll have a sound knowledge of the EU MDR regulation, providing a solid foundation to build upon. Additionally, we will thoroughly review the EU regulatory structure, enabling you to gain a complete understanding of the medical device landscape in Europe. This in-depth understanding will prepare you for any future updates to the EU MDR, giving you the skills to navigate regulatory changes with ease. Don’t miss out on this incredible opportunity to gain the knowledge and expertise you need to excel in the medical device industry.

EU MDR 201 – Implementation & Compliance

Our live online EU MDR 201 course is designed for individuals and organizations that need to understand how to implement the EU MDR in practice. Building on the knowledge gained from our EU MDR 101 course, you’ll learn about the steps involved in preparing for the transition to the EU MDR, including conducting a gap analysis, creating a compliance plan, and preparing for Notified Body audits. The course also includes numerous exercises and practical examples to give you hands-on experience in applying the information you’ll learn. By the end of the course, you’ll have the knowledge and skills to perform internal audits and gap assessments against the regulation, making this course an essential tool for consultants, industry professionals, and newcomers alike.

FDA 201 Course – Master FDA Regulatory Compliance

Are you seeking to develop a thorough understanding of FDA regulatory compliance and its integration with ISO 13485 for the medical device industry? Our meticulously crafted FDA 201 course is designed to equip participants with advanced practical skills expected of a Subject Matter Expert. Whether you’re new to the medical device sector or a seasoned professional, this course is tailored to meet your needs, providing comprehensive insights and actionable strategies to navigate FDA regulations effectively.

FDA 201: Foundations of FDA Regulatory Compliance; Integrating ISO 13485 for the Medical Device Industry. 

During the FDA 201 course, we will guide you through the entire process of designing and developing a medical device, starting with the critical importance of defining the intended use. From there, we’ll cover all the applicable requirements of the FDA regulatory framework, including those related to quality management systems, risk management, design controls, verification and validation, labeling, post-market surveillance, and many other topics. Join us in mastering FDA regulatory compliance and advancing your expertise in the dynamic field of medical device development.

Choose Your Delivery Method

We offer both self-paced and live online training options for our courses, catering to the needs of all learners. Don’t miss out on this incredible opportunity to gain the knowledge and expertise you need to excel in the medical device industry.

We’re confident that our training programs will provide you with the knowledge and skills you need to ensure compliance with medical device regulations. To sign up for one or more of our courses, simply click on the links below to register for the EU MDR courses. For inquiries or to register for the FDA 201 course, please contact us directly via email or phone.

Special packages are available for companies wanting to train their staff. Please contact us for more details.