To those who say quality is a burden I can see where they’re coming from. With QA/QC in place, a lot of money has to thrown into a process that hinders the launch of a product, but it is a necessary burden. Spending ~$500k on QA/QC is astronomically better than losing +$1Mil to lawsuits and recalls simply because QA/QC was “too much of a burden”. Yes, there’s a lot of paperwork and extra steps in assuring the product is safe for use; however, these standards are in place because carelessness in biomedical devices and drugs could very likely lead to hurt customers or worse. QA professionals will assure a product meets the standards of different organizations whom via extensive research and trials have formulated their standards to assure safety and efficiency. In the contrast, being overprotective or over-doing QA can lead to faults down the line; however, I feel as though in this case, more QA/QC is better up to a certain point.