Who should attend
EU MDR training imparts practical knowledge about the Regulation and registration of various classes of medical device in Europe.
This advanced certification course in EU Medical Devices also covers medical devices strategic management and planning process. Moreover, this course will demonstrate key skills for medical devices business skills and concepts specifically for EU. Most importantly, The course provides cased based learning. As a result, it is easy for participants to understand the concepts. Above all, this EU MDR training covers updates and changes in the new regulations which is important to learner who want strong foundation in EU medical device knowledge. Most importantly, this course provides walkthrough on the regulatory expectations of European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities.
In addition, this medical devices regulatory affairs course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.
The course can be completed at any place. So, it allows the user to stop and start at their leisure.
Moreover, user can access the course at own pace. Hence, it allows the user to stop and start at their leisure.
- Course Code: RYD-110
- Title of the course: Advanced Certification Course in EU MDR (ACEUMDR)
- Duration of the course: 1 Month
- Eligibility: Anyone who want to seek knowledge about EU MDR regulation.
- Nature of the course: Online Self Paced Learning. Course can be accessed online across anywhere 24×7.
- Course Certificates: Certificate will be provided at the end of the successful completion of the course
Who should attend?
- This course is ideal for Medical Devices Professionals, who are seeking to improve their skills in the EU MDR environment.
- Those who are entering into regulatory affairs from other areas within a device company (Pharmacists, Clinical Trials, Marketing and others).
- This course will be ideal for those working in Quality or Continuous Improvement departments in a medical devices’ industry.
- Moreover, this course will be beneficial for the regulatory affairs professionals who are working on medical device but do not have working knowledge of the EU medical device.
- Above all, this course will be great tool to enhance the skills in Business Development and Strategic Planning department in medical device.
This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of eu medical devices regulation and marketing authorization process in detail. Moreover, the course challenges students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also be eligible to receive the course study modules, which you can download by login to your course page.
Important Learning Features of EU MDR training:
- Online 24×7 access from anywhere. Hence, one can learn at your convenience.
- Hence, the course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
- Interactive E-lectures helps user to understand of the concepts effectively.
- Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.
Medical Devices Course Coverage Area
EU Medical Device Regulations (MDR and IVDR)
An overview of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), including their scope, key changes, timelines, and implications for manufacturers, distributors, and other stakeholders.
Classification of Medical Devices
Understanding the classification of medical devices based on their risk level and how it impacts the conformity assessment process.
Conformity Assessment Procedures
Explaining the different conformity assessment routes for medical devices, such as self-certification, notified body involvement, and the necessary documentation and steps for each.
Detailed guidance on creating and maintaining technical documentation, including design and risk management documentation, clinical evaluation reports, post-market surveillance, and vigilance reporting.
Clinical Evaluation and Performance Studies
The importance of clinical data in supporting the safety and performance of medical devices, and how to conduct clinical evaluations and performance studies.
Labeling and Packaging Requirements
Overview of labeling and packaging regulations, including the Unique Device Identification (UDI) system and other labeling requirements.
Post-Market Surveillance (PMS) and Vigilance
How to establish a post-market surveillance system, collect feedback from users, and handle vigilance reporting in case of adverse events.
Quality Management Systems (QMS)
Understanding the requirements of ISO 13485 and how to implement a robust quality management system for medical devices.
Authorized Representative and Importer Responsibilities
For non-EU manufacturers, the role and responsibilities of the authorized representative and importer in the EU market.
Guidelines on implementing the Unique Device Identification system for medical devices.
Clinical Investigations and Notified Body Interactions
Explaining the process of conducting clinical investigations and how to interact with notified bodies for conformity assessments.
Market Access and Post-Market Obligations
Procedures for obtaining CE marking, maintaining compliance, and fulfilling post-market obligations.
In Vitro Diagnostic Devices Specific Requirements
Specific requirements for in vitro diagnostic medical devices under the IVDR, including performance studies, performance evaluation, and performance evaluation reports.
Here you can find some medical device training courses for your reference.