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Quality consulting for re-certification
Project duration: 7 months
Brief description
The customer is about to be re-certified in accordance with EN 13485 by the relevant body. Compliant processes and documentation need to be created. The customer develops, produces and sells class IIb devices. As such, the specifications of MDD, MEDDEV, EN ISO 14971, 60601-1, 60601-1-6, 60601-1-8, 60601-2-24, 62304, 62366, 62353 ff need to be observed.
Supplement
The project uses common MS Office programs for the Windows environment.
Subject description
The following standards are used for the consulting and later implementation: EN ISO 13485 for quality management, EN ISO 14791 for risk management, IEC 62304 for software development, 60601-1-6 and 62366 for serviceability and usability, 60601-1 for general requirements for the basic safety of electrical medical equipment and 60601-2-24 for the particular requirements for the safety of infusion pumps.
Overview
- Industries medical technology
- Specialist tasks BPM: process design, ISO 13485, ISO 62304, project management, quality management, Usability
- DV tasks quality management
- System environment Client/Server, Internet/Intranet, PC systems/networks, standard software: industry systems
- Procedure model customer standard
Project period01.10.2014 - 23.04.2015
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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