Experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, identification and characterization, testing of medical devices, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery.