Maria is an experienced consultant in the field of regulatory requirements for medical devices intended for the European market. She has held positions with a Notified Body for several years, specializing in reviews of technical documentation for MDD compliance for a wide range of medical devices. Maria has an eye for detail and document structure, and she knows the importance of accuracy and clarity required to present the evidence necessary for MDD compliance.
“Why is a well-structured Technical File important?” ”All medical devices put on the European market must fulfill national legal requirements according to the relevant directive, such as the Medical Device Directive. Technical Documentation or a Technical File is evidence of compliance. A Technical file which is accurate and well-structured saves money and shortens time to market. A coherent documentation structure also facilitates future upgrades needed to meet changes in Medical Device Directives. ”