With this Bundle you’ll have the chance to get the major part of the documents that are needed for your the submission of your technical file. You still need to include your product and company data but this is a guided document that will help you fill it as quick as possible.
In case of support, you can still contact Easy Medical Device. We can build your technical file or review it to confirm compliance to MDR 2017/745.
Content of the Bundle
Technical File Documentation
This template will include the requirements as stated on Annex II and III of the Medical Device Regulation MDR 2017/745.
The GSPR template
It is build to answer to the requirements of MDR 2017/745 Annex I.
All the 23 requirements are mentioned and a support is provided to show the evidence that you are compliant.
The Declaration of conformity Template
This is the principal document that should be shown to the regulators but that should be also inspected by the Economic Operators. This template is build to contain all the information needed to comply to MDR 2017/745.
Technical File Checklist
I created this checklist to audit your current situation and define if you are compliant or if there are some actions to perform to be compliant. The objective of this document is to help you track the review of your files and report the status in an organized manner.