ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard ...
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related ...
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related ...
Use ISO 13485 2016 to show that your organization is consistently capable of providing medical device products that meet customer expectations and comply with ...
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ISO 13485:2016 is here. The world’s most popular standard for medical devices quality management has been revised for the first time since 2003.
ISO (the International ... Medical devices — Quality management systems — Requirements for regulatory purposes 1 Scope 1.1 General ... medical device(s) ...
ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 ...
BSI Medical Device Training: Helping to make regulatory compliance excellent with online, public and inhouse training courses from BSI.