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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
- Industries health care
- Specialist tasks Engineering, ISO 13485, ISO 14791, ISO 62366, IVDR, QS: Documentation, risk analysis, Risk Management
- DV tasks customised software further development
- System environment Client/Server
- Procedure model Waterfall Model
Project period01.09.2020 - 28.02.2021
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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