Medtech Quality Requirements: ISO 13485 Overview and Implementation Course (2 days)
This course examines the elements and implementation 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.
After Day 1, 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.
After Day 2, participants will understand:
- Practical implementation strategies of an ISO 13485 and 21 CFR Part 820 compliant quality system.
- Current trends in FDA audits
- Common industry trends and audit findings
Instructor: Certified Lead Auditor and Quality System Trainer, Jorge Sugranes, PSC Biotech