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IVDR compliance assessment for device (clinical chemistry)
Project duration: 6 months
Brief description
The customer's product is a compact benchtop solution for clinical chemistry tests in laboratories that want to analyze up to 50 samples per day. As the solution has aged, PTA was tasked with making the device compliant with new In-Vitro Diagnostic Regulations (IVDR). First, an IVDR compliance assessment was conducted, with PTA handling requirements engineering and management, risk management, and traceability.
Supplement
PTA was responsible for updating the requirements and risks to meet the latest IVDR standards and coordinating with the customer's team. Additionally, PTA ensured the traceability from risks to requirements (mitigations) to tests.
Subject description
Small labs and practices do not want to purchase large clinical chemistry devices. This device allows general practitioners to perform smaller clinical chemistry tests directly in their practice. As a result, samples do not need to be sent to a lab, and the patient receives a diagnosis more quickly.
Overview
- Industries health care
- Specialist tasks ISO 13485, ISO 14791, IVDR, Requirements Engineering
- DV tasks customised software further development
- System environment Client/Server
- Procedure model V-Modell
Project period01.09.2020 - 28.02.2021
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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