There are several layers of oversight that a medical device company will have to deal with. Empirical Consulting works in the last phase of development, when the product is finished and the decision to present it to the FDA for review is reached. At this time, they will do the necessary testing to ensure that any device meets different regulations. What kind of tests really depends on the medical device.
For example, for devices that replace bones, fatigue testing is required. The FDA requires all companies to show that any device can meet their minimum requirements for use in the real world. If someone needs a hip replacement, for example, they don't need an artificial hip that is only rated to last a year. The FDA does require testing to be completed by an independent company that has been licensed as qualified to provide the testing. It cannot be tested by the company that created the device, and it can't be tested by an unregulated company.
If a company thinks that they can improve on already existing medical technology, that will have to be tested and proven as well. General testing against the existing device, and independent documentation of those results by a medical device consulting company, can go a long way towards making the FDA see the light on the need for a new device.
There is also the issue of bone screws and pins. These devices are very important when they are used. The FDA requires proof that screws and pins sold to hospitals and surgeons will withstand the abuse they will go through once used in a bone. Independent testing shows that a company is very confidant about the products that they are selling.
When it comes to creating a device, a company needs oversight from companies that know the regulations about what devices need to be created in a clean room, need to be sterilized before shipping and so on. However, this is separate from the after creation needs. From testing medical devices for potential use, to making sure they meet the FDA's stringent requirements regarding fatigue rates, empiricaltech.com is the place to go.