According to me in the case of quality assuarance there are 3 main components: 1) Focus on quality: Mans FDA not only looks at design and production of devices but also beyond the baseline by looking for the critical quality practices having more outcomes. The practices for FDA involves altering deign as per the need of customers and increasing the speed of detecting errors. Most important is FDA practices library that helps manufacturers to improve quality and design. 2) Enhance Data Transparency: FDA had wide range of quality data including information from recall, inverse reports and adverse events. The data is proposed by many strategies that supports data quality. 3) Stakeholder Engagement: FDA works with stakeholders as well as Medical Device Consortium for device compliance and quality. And it moves further the meeting goes on with stakeholders for the case of quality.