Medical Device File Folder Structure

Medical Device File (Technical File) Folder Structure

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which, then be modified to suit your company branding/marketing requirements.

How will the folder structure help me? 

These folders provide a clear medical device file structure where supplementary files and data can be stored pertinent to your Medical Device File document.

These are laid out as per the medical device file structure and requirements of the Medical Device Regulations EU 2017/745 and In Vitro Diagnostic Regulations EU 2017/746. 

The information will be well organised and easier for internal/ external auditors to navigate through. 

The detailed folder structure will also help manage technical file reviews and updates. 

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.