| Course Description The one day course Introduction to ISO 13485, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, provides an insight in the use of the Standard as basis for a Quality Management System for Medical Device manufacturers. During the course requirements of ISO 13485 are reviewed and comparisons to business processes are made. Participants will gain an awareness of the contents and context of the Standard. Learning Objectives On completion of the training, participants will be able to: • Understand the scope and use of ISO 13485 as basis of Medical Device Regulations Worldwide • Interpret the clauses of ISO 13485 • Recognize the role and responsibilities of management Examination or testing During the course cases are used to verify the gained knowledge. Program overview • Environment of ISO 13485 in the Medical Device Industry • Introduction of ISO 13485 and comparison with ISO 9001 • Process approach • Documentation of a Quality Management System • Responsibilities of Management • Management of resources • Product realization • Measurement, Analysis and Improvement • Questions & Answers • Evaluation of the course and Closing Who should attend • Senior Management • Quality Managers • Regulatory Affairs Managers • Internal and external Auditors • Anyone involved with the implementation of the Standard ISO 13485 The number of participants is maximized to twelve to provide a stimulating and practical working environment. Level There is no prerequisite for this course but participants will benefit from a basic knowledge of the quality management systems, e.g. ISO 9001 or ISO 13485 Duration 1 day, including refreshments and lunch. Training material Course notes are provided on a USB stick. |
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