Earners have trained on an overview of Quality Management Systems (particularly ISO 13485 for medical devices). Benefits of quality system alignment/certification. Purpose, structure & requirements of ISO 13485: Quality Risk Management (ISO 14971), Management responsibility, Resource Management, Product realization, Measurement, analysis and improvement. Overview of ISO 13485 application process. Development of documentation. Preparation for applying for ISO 13485.

• Type Learning
• Level Intermediate
• Time Days
• Cost Paid