#Industry News
ISO 13485 on the road again
Since February, 13 2019, SFRI owns the new ISO13485:2016
ISO 13485 specifies the requirements of quality management systems (QMS) for the medical device industry. It is based on the requirements of the more general ISO 9001: 2000 standard, in the context of this industry.
The exact title of ISO 13485: 2016 is Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
Different aspects to be implemented concern:
compliance with regulatory requirements;
mastery of special processes;
risk analysis throughout product development;
clinical trials and long-term follow-up of these trials;
the organization of materiovigilance;
the control of the traceability of the configuration of each medical device delivered.
SFRI is proud to retain its ISO 13485 and CE marking! The hard work and especially quality is reflected in this certification that proves to the world that SFRI is a capable and serious manufacturer of the DIV.
