Beijing Amet officially obtained the ISO 13485 quality management system certification issued by BSI
Release time:
2021-05-14 09:11
Source:
Recently, Beijing Amet Medical Devices Co., Ltd. officially obtained the ISO 13485:2016 medical device quality management system certification issued by BSI British Standards Institute. The scope of this certification includes the design and development of Amet's products of a fully degradable peripheral vascular drug-eluting stent system and a high-pressure balloon dilation catheter.
The acquisition of this system certification signifies that the design and development process of the above-mentioned products of Amet fully complies with the requirements of the ISO 13485 quality management system, and the operation of the system has reached the corresponding international level; the acquisition of this certificate is also the future of Amet to customers and regulatory agencies. quality commitment, and at the same time will help Amet to expand overseas markets in the future.
About ISO 13485:2016
As an internationally recognized quality management system standard for the medical device industry, ISO 13485:2016 "Requirements for Medical Device Quality Management Systems for Regulations" has added a large number of best practices in the medical device industry on the basis of the previous version of the standard. The quality management system and regulatory registration and supervision are more closely integrated standards.
About BSI
Founded in 1901, the British Standards Institute (BSI) is the world's first national standards body and is currently the world's leading certification body. The certification issued by BSI has authoritative reputation and wide international recognition effect in the international market.
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