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.