REVIEW

Document review

DOCUMENT REVIEW

of your Technical Documentation

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.

PEBBLES

PEBBLES

  • Declaration of Conformity
  • Intended Purpose
  • Statement for systems/procedure packs (MDR, Art 22)
  • Declaration on particular substances (animal, human, medicinal)

STONES

STONES

  • Classification statement
  • PMS plan
  • PMS report

BOULDERS

BOULDERS

  • Instructions for use (IFU) and Labelling
  • GSPR checklist and List of applicable standards
  • Biological evaluation plan and report (MDR)
Since we need an in-depth knowledge of your product to create one of
the “BOULDER” documents, we initially perform a GAP analysis “CLEFT“.
Your benefit: together with the newly created documents you will
also receive a deficiency report of all GAPs in your Technical Documentation.
 

HILLS

HILLS

  • Clinical Evaluation Plan and Report including Literature Search
  • Risk Management including Plan, Analysis and Report
Since we need an in-depth knowledge of your product to create one of
the “BOULDER” documents, we initially perform a GAP analysis “CLEFT“.
Your benefit: together with the newly created documents you will also receive a deficiency report of all GAPs in your Technical Documentation.
 
 
 

MOUNTAIN

MOUNTAIN

We create the complete Technical Documentation of your medical device or IVD product.