GAP ANALYSIS

TD GAP Analysis

GAP ANALYSIS

of your Technical Documentation

GAP analysis of MDR/IVDR Technical Documentation:

A quick check for manufacturers, investors, and EC representatives!

Because many stakeholders are unsure about the quality and completeness of the Technical Documentation, we decided to offer a quick check. With this so called “GAP analysis” we systematically check, if your Technical Documentation is complete, readable (e.g. language, searchable), and up-to-date. Additionally, inconsistencies or obvious discrepancies catch the eye of our experts and are included in our report to you.

Since the Technical Documentation is the regulatory heart of your medical device or IVD product (MDR/IVDR), you need to know about all the gaps. Our GAP analysis will give you a comprehensive overview. This will enable you to focus on the biggest issues and gaps.

This is not only important if you are a manufacturer and therefore in the possession of your own Technical Documentation. It might also be important, if you are an investor or EC representative and you are unsure, if the quality of the documentation of your partner company is sufficient.

"The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner."

– MDR/IVDR, Annex II –

CLEFT

STARTER
500
  • what we check:
  • all documents existing?
  • documents readable?
  • documents up-to-date?
  • striking discrepancies?
  • what you get:
  • deficiency report

CANYON

ADVANCED
2.000
  • what we check:
  • all documents existing?
  • documents readable?
  • documents up-to-date?
  • striking discrepancies?
  • what you get:
  • detailed checklist with
    comments & instructions
  • official guidance documents
  • documents sorted into MDR/IVDR file structure

VALLEY

EXPERT
4.000
  • what we check:
  • all documents existing?
  • documents readable?
  • documents up-to-date?
  • striking discrepancies?
  • what you get:
  • detailed checklist with
    comments & instructions
  • official guidance documents
  • documents sorted into MDR/IVDR file structure
  •  
  • SPECIAL TD OVERVIEW*
Special Offer

* The “TD Overview” document is a summary and reference document, that gives you and the auditor a clear and structured overview over the contents of your complete Technical Documentation (Annex II and III MDR/IVDR).

Document Review

Sometimes, however, a quick check might not be enough for your purposes. Instead, you may need a detailed MDR or IVDR compliance check. In this case, a document review performed by our experts might me a better option. During the review process, our experts will check if all requirements of MDR/IVDR regulations, from applicable harmonized standards, as well as acknowledged guidance documents are fulfilled. This will enable you to get your documentation Audit-ready quickly and efficiently.

For a detailed MDR-/IVDR compliance check of single documents like the CER or your risk management file, please check out our review options.