Medtech Quality Requirements: ISO 13485 Overview Course (1 day)
This course examines the elements of ISO 13485 and FDA 21CFR Part 820 from a practical and holistic perspective applying the regulations, modern industry practices, industry trends, contemporary frequent audit findings, and real examples to clarify relevant points. Both regulations are critical for medical device companies who will be seeking approvals in the USA and the rest of the world.
At the conclusion of this 1-day course, participants will be able to:
- Understand the elements of ISO 13485 and FDA 21CFR Part 820 regulations.
- Interpret these regulations and its potential implications to the business.
- Apply ISO 13485 and FDA 21CFR Part 820 principles and concepts.
Instructor: Auditor and trainer, Jorge Sugranes, PSC Biotech