ISO 13485:2016 – Introduction and Implementation

Course Description

This course is certified by Exemplar Global.

The international standard ISO 13485:2016 forms the basis for an effective quality management system in the medical device industry and its suppliers. We recommend you join this seminar if you would like to familiarize yourself with the contents of ISO 13485:2016 and options for its practical implementation.

What are the requirements for the quality management systems of medical device manufacturers? At the heart of ISO 13485:2016 is a comprehensive process risk management to be integrated in all medical device-related quality management processes of the company, including outsourced supplier processes. Beside development and production of a medical device, processes have to be taken into account after the medical device have been placed on the market.

Our two-day seminar will provide you with basic theoretical knowledge regarding ISO 13485:2016 and the implementation workshop, will explain in detail how to integrate practically the requirements for a quality management system into your company's processes.

Course Contents

• Introduction to the legal and normative environment of ISO 13485:2016
  • Legal environment (national and international) and regulatory framework
  • Lifecycle of a medical device
  • Classification of ISO 13485:2016
• ISO 13485:2016 in detail
  • Process validation and risk analysis, documentation
  • Qualification and infrastructure
  • Development (design control, clinical data, validation)
  • Supplier management
  • Production control
  • Continuous improvement process (CIP): internal errors, complaints, risks
  • Corrective and Preventive Actions (CAPA), reporting process
• Workshop: deepen the knowledge about the chapters of ISO 13485:2016

Who Should Attend

• Medical device manufacturer and supplier’s personnel who will be involved in the launch of management systems or updating of the current management system
• Quality management officers (QMOs), product managers, regulatory affairs managers
• Consultants in the medical device industry

Course Objectives

• Based on ISO 13485:2016 you will know how to introduce respectively to optimize a quality management system in your company.
• You benefit from the detailed standard interpretation of ISO 13485:2016 by our experts.

Requirements

No requirements are necessary.

Methodology

This seminar addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.

As a participant, you will receive a copy of the standards book Quality Management and Risk Management for Medical Devices ISO 14971 and ISO 13485.