MDR/IVDR ready documents
You need Technical Documentation for your EU market launch? However, the road ahead is just too daunting right now? In this case, let us ‘be your lift’! Whether individual documents or the entire Technical Documentation: our experts work quickly, reliably and ensure the highest quality. Audit-ready documents are created in close consultation with you.
LET US BE YOUR "LIFT"
The Technical Documentation is comprised of a variety of different documents:
There are very short and rather simple documents like the “Declaration of Conformity” (like Pebbles), medium sized documents with moderate complexity like the “PMS Plan or Report” (like Stones & Boulders) and then there are long and complex documents like the “Risk Management File” or the “Clinical Evaluation” (like Hills). Additionally, of course, there is also the complete Technical Documentation with all the essential documents.
- Declaration of Conformity
- Intended Purpose
- Statement for systems / procedure packs
(MDR, Art 22)
- Declaration on particular substances
(animal, human, medicinal)
- Classification statement
- PMS plan
- PMS report
- Instructions for use (IFU) and Labelling
- GSPR checklist and List of applicable standards
- Biological evaluation plan and report (MDR)
- Clinical Evaluation Plan and Report including Literature Search
- Risk Management including Plan, Analysis and Report
We create the complete Technical Documentation of your medical device or IVD product.