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Fundamentals of EU Regulations for Medical Devices

Course summary
5 weeks
Online courses
Professional Training

Course description

Fundamentals of EU Regulations for Medical Devices

Are you ready for the new Medical Device Regulation (MDR)?

Published on May 5th 2017, the final text of the Medical Devices Regulation constituted major changes for the industry. This flexible online course offers students an excellent opportunity to understand the basics of the entire medical device product lifecycle in the context of these updates.

This course will allow you to engage with a leading expert in the field and come to grips with regulatory affairs, quality management systems, risk management, clinical evaluation requirements and general compliance aspects of medical devices.

The new MDR necessitates a degree of transformation for medical devices manufacturers, importers and distributors, including changes to classification and safety and performance requirements for proving compliance, among others. Designed for those new to medical devices, or needing a broad overview of the changes resulting from the MDR, this course will cover a variety of major topics to give an excellent understanding of the area.

Suitability - Who should attend?

This course is suitable for professionals who work in the medical device regulatory industry who need to understand the changes in the EU law. Particular areas may include:

  • Regulatory Affairs
  • Medical Device Development
  • Clinical Investigations
  • Chief Operating Officer – Doctors & Nurses etc.
  • Adverse Events Reporting
  • Research & Development 

Outcome / Qualification etc.

  • Grasp the changes that the medical device industry needs to facilitate to remain compliant with the new regulations
  • Understand how to submit your documentation to ensure your device is in line with the updated general safety and performance requirements
  • Familiarise yourself with the stringent clinical evidence requirements and vigilance reporting
  • Learn to classify your device under the new guidelines
  • Understand the post-market and surveillance requirements
  • Become familiar with the good practices for clinical investigations and evaluations reporting detailed in ISO 14155

Training Course Content

  • Module 1: Introduction to Medical Devices and the New MDR and IVDR
  • Module 2:  Borderlines and classification
  • Module 3:  General safety and performance requirements
  • Module 4:  Clinical evaluations and investigations
  • Module 5:  Risk assessment and management
  • Module 6:  Technical documentation
  • Module 7:  Quality Management System
  • Module 8:  Conformity assessment routes
  • Module 9: PMS and vigilance

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About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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