When you are buying this pack of documents you will have done already 80% of the job to submit your Drug-Device combination product assessment to a Notified Body.
Here is the type of format that your Notified Body is looking for:
1. Fully legible (including pictures, signatures etc)
2. Readily and searchable
3. Without any file/document access protection
4. Offering the structure and contents with clear identification of the
contents covered (e.g. via bookmarks, hyperlinks)
5. Offering unambiguous file and document identification (name, number, date, revision number etc.)
And this is what we offer with this package. All your information will be structured in a way that will help you fill the template easily. We included some guideline inside the document so you know exactly what to include in each section.
Drug-Device Technical File Documentation
This template will include the requirements as stated in Article 117 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.