A comprehensive overview of Brazil's Medical Device regulatory framework, including both Premarket AND Postmarket requirements. Learn what it takes to bring a product to the Brazilian market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Brazil is utilizing MDSAP. Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard.
By the end of this course, you should:
- Identify the legal and regulatory framework for medical devices
- Determine the correct classification for medical devices
- Understand how Brazil utilizes MDSAP
- Understand the premarket pathway(s) and requirements for medical devices
- Understand the Quality Management System regulations required to market a medical device or IVD in Brazil
- Understand the post-market requirements for medical devices
By completing/passing this course, you will attain the certificate Medical Device Certificate
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