- Do you have a clear understanding of how to put the CE Mark on a medical device?
- Does the complexity of the product directives confuse you?
- How up-to-date is your organization on the new standards for EU medical device quality systems and risk management EN ISO 13485:2012 & EN ISO 14971:2012?
Attend this two-day interactive course and get a better understanding of the Medical Device Directive (MDD) and its latest implementation tools.
This course will address the details of the MDD and includes other significant issues such as the Quality Management System (EN ISO 13485:2012), Risk Management (EN ISO 14971:2012), Clinical Evaluation (MDD Annex X), the role of harmonized standards, and the vigilance system.
This seminar will provide attendees a comprehensive training on how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it.
This course will also include practical exercises that apply the principles and help solidify learning. Attendees will receive detailed checklists that help classify devices, analyze and apply the essential requirements, and conduct internal quality audits.
Learning Objectives:
- Understand the role of product directives in the EU
- Learn the medical device classification system and how to apply it
- Comprehend the conformity assessment paths and how they apply to particular devices
- Learn the role of EN ISO 13485:2012 and its relationship to conformity assessment
- Understand the requirements for Risk Management and the use of EN ISO 14971:2012
- Understand the MDD Essential Requirements and document compliance
- Learn the role of the harmonized standards in demonstrating the Essential Requirements
- Integrate the Clinical Evaluation in the MDD into the essential requirements and risk management processes
- Apply the vigilance system including reporting, Field Safety Corrective Action, and Field Safety Notice
- Prepare for Unannounced Inspections