You will gain a grasp of the essential criteria during the course, which will provide you with:
Knowledge of the EU's Regulatory Affairs for medical device reporting training is crucial for anyone working in top management, management, R&D, design, production, supply chain, customer support, or sales.
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Understanding requirements from subcontractors, suppliers, OEMs, authorized representatives, importers, and distributors will improve interactions between them and the legitimate manufacturer.
A starting point for later learning about the execution of CE marking initiatives in the USA.
The course is particularly appropriate for:
- Regulatory Affairs (RA) professionals who are new to the field, those who are taking on more responsibilities there, and those who are unfamiliar with the European MDR.
- Top management, managers, or project participants in QM/QA, R&D, design, manufacturing, supply chain, customer service, and sales who work with regulatory affairs departments.
- Personnel employed by businesses that collaborate with producers of medical devices, such as subcontractors, suppliers, OEMs, authorized representatives, importers, distributors, auditees, etc.
- Please be aware that in vitro diagnostic devices will not be covered in this course. If you require further in-depth information, for example, regarding the implementation of medical device reporting training.
- No formal prerequisites are required for this course, although participants will benefit from having a basic grasp of quality management and/or the usage, design, or manufacture of medical devices.
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Delegates will be able to after the course to:
- Describe the main guidelines and ideas of the clinical trials online course.
- Refer to the relevant factors to determine whether and to what degree MDR will affect your organization.
- Describe the terms used in MDR.
- Describe the organization and implementation of the Regulation.
- Recognize the manufacturers' partners who are impacted by the Regulation.
- List the essential procedures in a compliance evaluation.
- Describe the primary effects of MDR on the quality management system (QMS).
- Recognize the demands for updates and post-market surveillance.
Connect with World Compliance Seminars website today for more desired info.
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