I agree with most of the participants in terms of the importance of Quality Department in a medical device industry. I’ve worked as a Quality Engineer for 2 years in a medical device company and I’ve witnessed the importance of QA/QC. I agree that due to documentation and other quality requirements may delay the project. However, it helps the overall company in releasing a successful product in the market. Furthermore, there are external audits conducted by the notified body such as FDA, or ISO 13485 audit. And there needs to Quality Management System (QMS) established by the company to successful pass the audit. All in all, well established QMS and the QA/QC department prevents the company get shutdown. Thus, it’s better to pay off 60k (+) to a quality engineer then to deal with a lawsuit.