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IVDR Compliance Assesment for IVD Geräte

Project duration: 6 months

Brief description

This semi-automated device needed a product update after a long and successful time on the market. One reason for the update was the new In-Vitro Diagnostic Regulations (IVDR). Another reason was that certain hardware components were no longer manufactured. PTA revised the requirements for the device and conducted a new risk assessment.

Supplement

Between the initial launch of the product and the time of the product update, the customer revised and adjusted their quality management system three times. The requirements could be divided into different areas. For example, the requirements for measurement technology remained largely unchanged, but the connectivity requirements changed from a serial interface to USB-C.

Subject description

The customer's solution is a small device for diagnostic urine tests. The semi-automated device can measure the following parameters: pH value, leukocytes, nitrites, proteins, glucose, ketones, bilirubin, and blood in urine.

Overview

Project period01.09.2020 - 28.02.2021

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Ole Knudsen

Key Account Manager

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