Creating and Maintaining Technical Files and Design Dossiers
Our Creating and Maintaining Technical Files and Design Dossiers one-day training course is designed to support manufactures by confirming current regulatory requirements of technical documentation.
The aim of the course is to speed the Notified Body certification process and enable manufacturers to sell compliant devices within the European Union.
On completion of training you will be able to identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers.
Participants should have experience with or basic knowledge of European Device Directives – 93/42 EEC and 90/385 EEC.