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BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package
BS EN ISO 13485 and BS EN ISO 14971 (British Standard)
The BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system accociated with the use of medical devices. The BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package includes:
- BS EN ISO 13485:2016+A11:2021
- BS EN ISO 14971:2019+A11:2021
BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package includes:
British Standards Institution [bsi]