This week's throwback episode of Beyond Clean gives listeners a look inside the process of gaining 510k approval and building a quality system that includes a risk analysis component. While there can be great pressure to cut corners in sterile processing in order to meet demand, Shawn Flynn , Consultant, Entrepreneur, and Medical Device Inventor, encourages technicians and managers to have the backbone to say no and advises that the good device representatives will support the smart and safe decision. Hank Balch and Justin Poulin then raise the topic of UDI (unique device identifier) regulation and the interview closes by addressing the important question of whether employing an expert in sterile processing would help the technical writers develop instructions that can be more easily interpreted. Tune in now!  CE Credit -> https://www.beyondclean.net/ce-credit-hub #BeyondClean #WeFightDirty #sterileprocessing #podcast #season1 #throwback #510K #medicaldevice #surgery #MDR #CSSD #SPD