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Person responsible for quality at a medical equipment manufacturer
Project duration: 4 years, 11 months
Brief description
The task of being responsible for quality is taken over on a mandate basis for a medical equipment manufacturer which develops, manufactures and sells infusion pumps (medical equipment class IIb).
Supplement
The mandate comprises: - Continuous checking of process, specifications and work results to see that they conform and delivery the necessary performance - Improvement in processes, instructions and specifications - Carrying out internal audits – continuous product risk assessment - Processing any vigilance cases and instigating corrective actions - Communication with authorities and the named office – consulting for internal offices and for suppliers - Observation of the development of standards and statutory specifications - Transferring and improving the quality management handbook according to the new DIN ISO 13485:2016
Subject description
Specifications and standards used: Medical Devices Directive (MDD), MEDDEV, Medical Product Ordinance (MPV), Therapeutic Products Law (HMG), DIN ISO 13485 for the quality management system, EN ISO 14971 Risk management for Medical Devices, 60601-1 General requirements for basic safety of medical devices, 60601-1-2 Electromagnetic compatibility, 62366 / 60601-1-6 for usability, 60601-1-8 Alarm systems in medical electrical devices, 60601-2-24 Particular requirements for the basic safety and essential performance of infusion pumps and controllers, 62304 Software lifecycle, 62353 Testing after repair.
Overview
- Industries medical technology
- Specialist tasks GxP/GMP, ISO 13485, ISO 62304, project management, quality management
- DV tasks organisational consulting
- System environment PC systems/networks
- Procedure model V-Modell
Project period01.02.2015 - 31.12.2019
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
Service
Industries
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