Thursday, January 20th 2PM ET with Becky Gilsdorf

Objectives: 

• Review standards and best practices for medical device manufacturers (ISO 13485, FDA Part 820 Quality System Regulation)
• Explain Good Documentation Practices and general principles on Instructions for Use (IFU)
• Overview of Design Control and the examine the role it plays in manufacturing medical devices
• Discuss the complaint handling process and how performing this effectively prevents Quality concerns