IVDR Tools and templates

Since the possibilities for on-site trainings or classroom sessions have been limited due to the recent COVID-19 outbreak, Qarad has created a brand new solution to share its experience with others: Qarad Academy IVDR tool and template packages!

We selected the most intriguing topics of the IVDR and per topic, a specific package was created. These self-explaining packages consist of tools and templates specifically developed by our regulatory experts to help you create the necessary documents in line with the IVDR in order to comply to its high standards.

In case you would need assistance in how to use our templates, you can opt to buy our promotion pack which includes 2 hours of consulting!

Compilation of an IVD STED file

Intended Use template
How to formulate a clear intended use for your products?
Summary of Technical Documentation Templates
- General STED template
  IVDR Annex II
- STED for Post-Market Surveillance
  IVDR Annex III)
General Safety and Performance Requirements
- GSPR Checklist
- Comparison GSPR – ERC:
  What are the differences between the requirements in the IVDD vs. the IVDR?
- List of harmonized standards under the IVDD

The Clinical Evidence Requirements

Intended use template
How to formulate a clear intended use for your products?
Performance Evaluation Plan Template
Performance Characteristics and list of CLSI documents
Analytical Performance Report Template
Clinical Performance Report Template addressing all possible elements:
- Literature Review
- Published Experience gained
- Clinical Performance Studies
Performance Evaluation Report Template