Training Courses

CE Marking for Medical Devices Training Courses

Our CE marking training portfolio is developed to assist you in the certification process for qualifying medical devices for the European market.

CE Marking for Medical Devices Training Courses

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Become adept in the CE marking process and regulations for medical devices

Our training will help you and your organization learn the key requirements, concepts, and processes to comply with the EU MDR 2017/745 or EU IVDR 2017/746 to support the CE marking for medical devices. Whether in-person or virtual, our live sessions use accelerated learning techniques, securing your thorough comprehension through interactive workshops and lectures. Also see our on-demand e-learnings and free webinars for flexible learning options.

Get essential knowledge to understand the regulatory affairs of medical devices in the EU and the demands of the suppliers, subcontractors, importers, and distributors, allowing better relationships between them and manufacturers.

Get European market access for medical devices

CE marking is the medical device manufacturer’s claim that a product meets the general safety and performance requirements (GSPR) of all relevant European medical device regulations and is a legal requirement to place a device on the market in the European Union.

Discover how our training can help you navigate the requirements for patient safety and device performance necessary for medical device product launches.

Popular CE marking for medical devices training courses

Below, you'll find popular courses with descriptions and direct links to our BSI Learning Marketplace, where more information is provided, including enrollment.

Learn the key requirements, concepts, and overall process for CE marking under the EU MDR 2017/245. Get vital insights for regulatory affairs roles across various sectors, facilitating smoother relationships between stakeholders, obtaining compliance with MDR requirements, and enhancing market access within the EU.

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This is designed to guide you through MDR implementation. Find out best practices to implement a compliant QMS and prepare a thorough technical documentation package to obtain CE mark for your medical device. Focus on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, post-market-surveillance (PMS), transparency, and traceability.

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Learn the key requirements, concepts, and overall process for CE marking under the EU IVDR 2017/246 for getting in vitro diagnostic medical devices in the European market. Explore the risk classifications and the conformity assessment routes.

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This is designed to guide you through IVDR requirements implementation to obtain and maintain the CE mark for in vitro diagnostic medical devices. Learn more about IVD classification rules and conformity assessment routes. Increase your knowledge on general safety and performance requirements in product development, performance evaluation, and clinical evidence.

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Learn the key requirements, concepts, and overall process for CE marking under the EU MDR 2017/245 on own schedule and pace. Get vital insights for regulatory affairs roles across various sectors, facilitating smoother relationships between stakeholders, obtaining compliance with MDR requirements, and enhancing market access within the EU.

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Learn the key requirements, concepts, and overall process for CE marking under the EU IVDR 2017/246 on your own schedule and pace. Understand how to get in vitro diagnostic medical devices into the European market. Explore the four risk classifications and the conformity assessment routes.

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This is designed to guide you through IVDR requirements implementation to obtain and maintain the CE mark on your own schedule and pace. Learn more about IVD classification rules and conformity assessment routes. Increase your knowledge on general safety and performance requirements in product development, performance evaluation, and clinical evidence.

See more details and enroll.

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