YOU CREATE - WE REVIEW
Your Technical Documentation is out-dated and you are unsure if it is MDR-/IVDR-ready? Our experts will do a thorough compliance check of single documents or your complete Technical Documentation. Our experts will review your documents and provide a detailed assessment considering the latest harmonized standards and regulations. With our guidance, you will have your MDR-/IVDR documents ready in no time.
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.