When starting a medical device company, it is very important that the validation processes for the devices are followed. As others have mentioned, it is key that the validation processes guarantee that the needs of the customer are met. There are specific regulations to follow according to the FDA for validation processes to ensure the best quality product is released. The validation process that is followed for the device should fulfill certain requirements specifically proposed for them. In addition, when validating the product, it is important to take the safety of the device into consideration. When improper validation processes are followed, there can be penalties when auditing is done. As a result, this could cause a setback for the product and the company, itself. The validation process accounts for any issues that may arise and makes sure the device follows protocols.