Course Structure

The course duration is determined by client needs/requirements.

A sample course breakdown is as follows:

• Quality Management definitions, concepts, and guidelines
• Purpose of the ISO 13485:2003 series
• Requirements of the ISO 13485:2003 standard
• Conducting the Gap Analysis
• Getting Top Management buy-in
• Managing Human Resources/Change Management
• Gathering Preliminary Data
• Establishing the Controls Measures
• Verification and Validation
• Operational Controls
• Risk Management
• The Audit Registration process

Course Assessment

The delegate is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.

Training Methodology

Accelerated learning is the most advanced teaching and learning method available today. It's a total system of enhancing and speeding up both the design and learning process. What makes accelerated learning so effective is that it's based on the way we naturally learn. It does this by actively involving the whole person, using physical activity, creativity, collaboration among learners, variety that appeals to all learning styles, contextual learning with real-world immersion, the creation of a positive physical, emotional, and social environment and other methods designed to get people deeply involved in their own learning.

What's Included on the course

• Comprehensive Course Manual
• Delivery by Expert (s) with real life experience 
• Additional Handouts
• Digital Training Certificate of Attainment and/or Successful Completion