In Europe, products classified as medical devices are generally subject to stringent regulatory requirements to ensure the product’s performance as well as safety. And to maintain patient safety, the EU introduced the EU Medical Device Regulation that is transforming and modernizing the older Medical Device Directive. Whether you are new to regulatory affairs, the EU MDR or are branching out from other areas of the wider medical device industry, EU MDR Training Coursewill detail the EU regulatory requirements throughout the entire product life cycle.

Complemented with practical exercises and open discussions, you will gain a comprehensive overview of the essential European regulatory requirements to consider as you prepare for MDR implementation, including the device classification, European regulatory landscape, conformity assessments, documentation, and labeling requirements, risk management, post-market considerations, and EU MDR Clinical Evaluation Report.

Simply put – theimplementation of European Medical Device Regulations is the primary requirement while demonstrating compliance to regulatory requirements while placing the products in European Market for the Medical Device manufacturers and to place CE marking on the products. This is why learning EU MDR Training Course is vital.
Who Is This Course For?

• Regulatory Affairs professionals looking to enhance their skills in the regulatory environment!

• Those moving into Regulatory Affairs from other areas within a medical device company (Marketing, Clinical Trial Evaluations, and others).

• Anyone wishing to update their knowledge on EU regulatory affairs!

Besides,EU MDR Training Course, we at MDR Consultants also offera Medical Device Single Audit Programthat defines the expectations of the European Commission, as well as medical device manufacturers, notified bodies, and member state competent authorities.

Engaging in our courses ensures that both academic and practical qualifications do not become out-dated or obsolete. This allowsindividuals to continually ‘up skill’ or re-skill themselves, regardless of occupation, age, or educational level. So, if you are looking for the same, feel free to browse www.mdrconsultants.com or reach out to our skilled experts and they will be more than happy to assist you!




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Email: [email protected]
Phone: (786) 306-0227
Website: https://www.mdrconsultants.com