Introduction to the ANVISA Quality Systems Regulations for Internal Auditors

Companies wishing to sell medical devices or IVD products in Brazil must obtain ANVISA approval prior to placing their product on the market. To achieve approval, manufacturers must demonstrate the safety and quality of their products.

Optimize your auditing skills with a deeper insight of ANVISA Quality Systems Regulations and learn what to look for in a quality management system (QMS) that is compliant with ISO 13485.

This course enables a clause-by-clause understanding of ISO 13485, which outlines the comprehensive requirements of an effective QMS. Develop your understanding of ANVISA Quality Systems Regulations and what to consider when auditing in conjunction with ISO 13485.


Who should attend?

  • Quality Managers
  • Internal Auditors
  • Regulatory Affairs Managers

Note: Knowledge of the ANVISA Quality Systems Regulations is a prerequisite for this course.

What will I learn?

You will learn about:

  • ANVISA Regulation requirements
  • What to consider when auditing the requirements as part of an internal audit in conjunction with ISO 13485

How will I benefit?

This course will help you:

  • Prepare, conduct and follow-up on ISO 13485 compliant QMS audit activities
  • Gain the skills to assess an organization’s capability to manage its Quality Management System
  • Offer confidence to customers and suppliers that a device meets regulatory requirements
  • Write factual audit reports and suggest corrective actions
  • Enhance customer satisfaction though effective audit application and commitment to continual improvement

What's included?

  • Training course notes
  • Lunch