DFW ASQ Biomedical Discussion Group presents: An Introduction to Design Controls
This topic expands on what is outlined within Design Controls as per FDAs Code of Federal Regulations 21 CFR 820.30. This is a great introduction to the knowledge base of Medical Devices compliance for new engineers who have little exposure to regulated devices to develop an understanding of these FDA regulations. At the same time this topic enables veterans in the Medical Device Industry to share their vast knowledge and experience with those new to the industry through discussions and interactions which are highly encouraged in our monthly meeting. This topic also provides a refresher to those who have been away from the Medical Device arena and are looking to have a quick recap of the regulations.
Featured Speaker: Vikram Gaonkar, ASQ CSSGB, CQA, CQE, CSQE is a Sr. Development Quality Engineer with Abbott.