Technical File Review and Gap Analysis

Technical documentation may be assessed by an external notified body for participation in a conformity assessment procedure in accordance with the MDD, IVDD, MDR or IVDR. Technical documentation should comply with the requirements laid down in those acts.

How can we help?

Our experts have many years of experience in the creation and evaluation of technical documentation and, thanks to their experience in supervisory authorities and notified bodies, they also have an appropriate approach to technical documentation evaluation. Through documentation evaluation or a zero audit at the company’s headquarters, we can draw attention to key aspects related to the manufactured products and adapt the technical documentation to current legal requirements.