PathPoint Macro - An IT-product for automationand streamlining gross patholog

Purpose and goal:

The purpose of the project is to fulfill the regulatory requirements for a medical device, named PathPoint Macro, which streamlines work in laboratories within histopathology.

The goal of the project has mainly been to establish a quality management system according to ISO 13485 and increase management´s knowledge of the regulatory requirements.

Both project goals have been achieved and the company today has a quality management system for which the management is responsible. Expected results and effects: Diagnostic assessments by laboratories are crucial for treatment decisions in, for example, cancer.

PathPoint macro is a product that streamlines the documentation of incoming tissue samples as a basis for the diagnostic assessment. For this purpose, the product uses advanced camera technology, image analysis and drawing tools. The project has established a quality management system to meet the regulatory requirements for the product.

With the product, the laboratory can streamline workflow and increase diagnostic precision, leading to better treatment decisions. Approach and implementation:

An external expert has conducted a series of workshops with the management to review the regulatory requirements in each area and together with the management develop drafts of standard operating procedures. The management has since independently completed and implemented them in the business.

The working method has naturally contributed to the transfer of knowledge to the company where Vinnova´s support in buying in external expertise has been crucial. The project kept its budget, but took longer to complete due to high workload.