Before any new medical product can be made available to patients, it needs to demonstrate that it complies with the requirements set out by the relevant regulatory bodies in the territories where the product will be made available.
The purpose of these requirements is to ensure, as far as is possible, that a product is safe to use and that it performs in the manner the manufacturer says it does.
Meeting the requirements of the regulators is a significant undertaking and as a result dictates much of the downstream development process for healthcare technologies.
The regulatory process for new healthcare technologies is complex. It is important to understand the regulatory framework and how it might apply to your technology as you can collect data and implement processes to comply with that framework during the course of your project.
In addition to demonstrating that your product is efficacious and safe, in many territories there is also an expectation that the technology has been made within guidelines that ensure those processes are robust and consistent.
This is achieved through the implementation of quality management systems.