Medical devices and ISO 13485:2003
June 28th, 2009
Practical Control is currently working towards ISO 13485:2003. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
This will further strengthen Practical Control’s position in the product design and development of devices for Telehealth, assisted living and in vitro diagnostics.
All requirements of ISO 13485:2003 are specific to organisations providing medical devices, regardless of the type or size of the organisation.
