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Risk Manager 3.0
Project duration: 9 months
Brief description
As part of the revision of the Quality Assurance Procedures (QVA) for Product Risk Analysis of IVD products, the tool has been significantly modified to meet the new requirements. For this purpose, the heterogeneity of the product landscape had to be analyzed, the scope estimated and an optimum determined in order to meet the requirements on the one hand and to keep the financial costs of changing the documentation of various affected products in check on the other.
Supplement
The revision of the QAP required a deep understanding of ISO 14971, IVDR and the standards IEC62304 and 13485, as well as the risk management characteristics of various other projects. Based on this, a concept was developed and discussed with various stakeholders in order to define a practicable optimum. The core of the implementation was the new risk assessment system and the definition of the channels of influence for this activity.
Subject description
Implementation of IVD Riskmanagement in Organisationen.
Overview
- Industries health care
- Specialist tasks Change Management, data analysis, Defect Management, FDA, ISO 13485, ISO 14791, IVDR, process analysis, product development, Prototyping, QS: Method automating, QS: Softwaretest, QS: Testmanagement, Requirements Engineering, Risk Management, work analysis
- DV tasks customised software further development
- System environment e-Business
- Procedure model V-Modell
Project period01.07.2019 - 12.04.2020
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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