The objective of this course is to provide the students with top to bottom understanding of the Quality Management System Regulation (QMSR) and the interpretation clause -by clause of this regulation for a medical device manufacturer. Throughout the course, students will engage in hands-on learning experiences, applying their knowledge of regulation requirements to tackle real-world case scenarios typical of the medical device industry.

At The End Of The Course You Will Be Able To

• Understand the importance, purpose, and the framework of general requirements for the design and manufacture of medical devices per FDA Quality Management System Regulation (QMSR).
• Know key factors to comply and maintain compliance to the QMSR.
• Understand how the company’s quality management system fulfils and is connected to the FDA QMSR.
• Learn the general requirements from all Sub-parts Quality Management System Regulation (QMSR) and how they correlate to the company quality system to support day-to-day activities.
• Experience and apply FDA QMSR requirements to solve in class real case situations that could be faced by a professional in this industry and to maintain compliance according to the standards.

Course Content

1. Change context
2. Scope
3. Denitions
4. Incorporation by reference – ISO 13485
   • Quality Management System.
     • General requirements
     • Documentation requirements
   • Management responsibility.
     • Management commitment
     • Customer focus
     • Quality policy
     • Planning
     • Responsibility, authority and communication
   • Resource management.
     • Provision of resources
     • Human Resources
     • Infrastructure
     • Work environment and contamination control
   • Product realization
     • Planning of product realization
     • Customer-related processes
     • Design and development
     • Purchasing
     • Production and service provision
     • Control of monitoring and measuring equipment
   • Measurement, analysis, and improvement
     • Control of nonconforming product
     • Analysis of data
     • Improvement
5.  Requirements for a Quality Management System
6. Control of records
7. Device labeling and packaging controls