We offer our support in the realization of a strategic internal audit, created to guarantee the conformity of your technical documentation and to answer to the CE and FDA marking requirements.
An audit is a key step for manufacturers of medical devices. It is essential before the submission of your Usability Engineering File to a notified organism.
Our method is based on a process cut into three phases: the definition of a personalized audit, the identification of the risks and opportunities and the efficient implementation of this audit program to maximize your chances to succeed.
