|
 |
• Provide guidance on approval routes and necessary certifications
•
Guidance on classification
•
Guidance on electrical safety and Electro-Magnetic Compatibility (EMC) testing.
•
Provide guidance on applicable standards and proper use of these standards
•
Provide procedures for creation and archiving of technical files and related processes
• Create technical files and declarations of conformity for the medical devices directive
|
|
|
