The regulations are written by people who do this for their career. That means they need a form of compensation. The fee(s) are used to compensate the employees who help write these regulations. These regulations show the quality of product that company is willing to pay for to have excellent quality for their medical devices. The saying goes “you get what you pay for”. To want a hip stem implant to last you 20 years as opposed to 10 years requires more effort to enhance the quality of the product. The company that you know has more certifications means they take what they do more seriously, especially in regards to medical devices. The company I intern for is only ISO 9001 certified for quality management system. For a medical device company just to have this ISO certification isn’t enough for the FDA. The company will be willing to spend the money on the various certifications because they want to ensure safe and effective products are being used on people.