Thursday, January 20th 2PM ET with Becky Gilsdorf


  • 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