Technical File Development

Our Experience

In order to demonstrate that your device meets the regulatory requirements for safety and efficacy, a technical file needs to be developed. No matter what class of device you fall under it is mandatory to have the objective evidence to prove how the device was designed, manufactured and tested.

Depending on the target jurisdiction for your submission, the requirements and format may vary. With experience compiling technical files for Class 1 through to Class 3 and active implantable devices, we can help navigate the hurdles.