FDA regulations tells the manufacturer that their product is complaint with regulations but does not offer any method to improve the quality of their product .The FDA increased scrutiny on inspection forced the industry to make changes that protect the end customer which causes an increase in price of product. everything we are focus on regulation compliance standpoint really inhibits us from truly driving after the quality improvement of our product. Medical Device Discovery Appraisal(MDDA) program helps the agency and medical device manufacturer to see quality assurance in new light. The program is designed to improve the quality of product with end goal of benefiting patients but also offers cost and efficiency benefits to manufacturer. FDA pushes quality over compliance, enhanced transparency, stakeholder engagement .It is important that everyone in the organization understands what the quality goal of the organization are so that they can properly align the procedure and principles that forms the overall quality policy for the company.