The objective of the course is to provide students with the understanding of the ISO 13485:2016 and the quality management systems requirements which are essential to organizations involved in the design, production, installation and servicing of medical devices and related services.

Through hands-on activities and case studies, students will gain valuable experience in navigating compliance challenges and addressing quality management issues.

At The End Of The Course You Will Be Able To

• Understand the general connection and differences between the ISO 13485 and the 21 CFR Part 820.

• Know key factors to comply and maintain compliance to the ISO 13485.

• Understand how a company’s quality management system fulfils and is connected to the ISO 13485.

• Learn to interpret ISO 13485 general requirements in the specific context of the medical device industry.

• Learn the general requirements from each clause of the ISO13485 and how they correlate to the company quality system and procedures.

• Experience and apply ISO 13485 requirements to solve real case situations during the class that a professional in this industry could face to maintain compliance.

Course content

1. Overview
2. Quality management system
3. Management responsibility
4. Resource management
5.  Product realization
   • Planning of product realization
   • Customer-related processes
   • Design and development
   • Purchasing
   • Production and service provision
   • Control of monitoring and measuring equipment
6. Measurement, analysis, and improvement
   • Monitoring and measurement
   • Control of nonconforming product
   • Analysis of dataImprovement