Technical Files
Technical Files are required for all products and are required to
include the following content:
* Description of the device and it's intended purpose
* The rationale used for classification & Conformance route
* Risk Management
* Results of compliance to the Essential requirements
* List of all referenced standards
* The Manufacturing processes for the product
* Design Dossier
* List of raw materials used (specifying critical components)
* Product documentation (User/Instruction Manual etc.) and
* Retention period for quality documentation & product life
* Vigilance System
* Post Production Feedback etc.
* Documentation Maintenance
* Declaration of Conformity
* European Representative details
* Registration with the competent Authority of the country in which the
product will be available
AQAS will work with you, consolidating your data with the systems
required to comply with the Technical File
E-mail: sales@aqas.com.au