Medical Device Regulation (MDR) 2017/745/EU Training

Our Training Content

This comprehensive training program covers all important aspects of Regulation 2017/745/EU. Our training content includes the following topics:

• Fundamentals and Objectives of the Regulation: A detailed examination of the general scope, coverage, and goals of 2017/745/EU.
• Categories and Classifications of Medical Devices: Classification of devices, risk management, and classification criteria.
• Market Surveillance and Compliance Requirements: Market surveillance procedures, compliance assessment processes, and required documentation.
• Clinical Evaluation and Performance Assessment: Clinical evaluation requirements, performance tests, and related standards.
• Safety and Quality Management Systems: Safety standards, implementation and monitoring of quality management systems.
• New Requirements and Regulations: Recent updates in the regulation, transition process, and impacts of changes.

Training Method

Interactive Presentations: Dynamic and interactive presentations prepared by subject matter experts.

Current Information: Learning through real-world scenarios and case studies.

Q&A Sessions: Interactive sessions where participants can directly ask questions to trainers.

Assessment Tests: Tests to reinforce knowledge and assess understanding of the regulation.

Who Should Attend?

This training is designed for personnel of notified bodies, auditors, technical experts, medical device manufacturers, importers, distributors, quality management specialists, clinical research sector employees, and healthcare professionals. It is suitable for those seeking in-depth knowledge of Regulation 2017/745/EU.

Training Dates and Registration

Our trainings are conducted online with flexible time slots. For registration and more information, please visit our website or contact us at support@pcatrainings.com.tr.

What Will You Gain from the Training?

Up-to-Date Information: Gain the most current and comprehensive information about Regulation 2017/745/EU.

Compliance: Ensure your medical devices meet legal requirements and enhance market access if you are a manufacturer.

Expertise: Learn from industry experts and become proficient in the best practices in the field.

As PCA Education Institute, we are here to support your success in the industry by providing the most comprehensive and up-to-date training on Regulation 2017/745/EU.