Technical Documentation: proof of sound development
The technical documentation is your ticket to the medical technology market, as every medical device consists of two components - the device itself and its product file. Regardless of the product classification – whether you want to launch a class I, IIa, IIb, or class III product - technical documentation is always required.
The technical documentation contains detailed information about the medical device. This includes, besides the actual technical product information, specifications about development, manufacturing, verification and validation, as well as information regarding the application of the product.
By means of the technical documentation, you as manufacturer prove the conformity of your medical device with the regulations of your target countries. It serves to give evidence of compliance with the essential requirements for European CE certification, which is the prerequisite for the approval of a product in your target country.
The technical documentation should be available to the supervisory authorities for inspection across the entire product life span, but must be hold accessible for at least five years after end of production (15 years for implants).
Comission us to provide the documentation and we will start working on it promptly. We hardly need any time to familiarize ourselves with the topic, because we are experts at it. Compliance with regulatory requirements is our daily business and with our wide range of expertise we make sure that they are adhered to in your documentation. The result: finalized documents ready to be signed using your templates.
Our services in this field
T: +49 621 123469-16
"My team includes medical engineers, computer scientists, physicists, and biologists; we are experts and allrounders – and certainly exactly what you need."