ISO 13485 Consultants

	ISO 13485
	ISO 13485 Certification and ISO 13485 documentaion from professional ISO 13485 consultants Medical devices -- Quality management systems -- Requirements for regulatory purposes
	ISO 13485 is an ISOstandard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture ofmedical divices.
	Other specific differences include:
	» the promotion and awareness of regulatory requirements as a management responsibility, will providing resources and during reviews » controls in the work environment to ensure product safety » focus on risk management activities and design transfer activities during product development » specific requirements for documentation and validation of processes for sterile medical devices » specific requirements for verification of the effectiveness ofcorrective and preventive action.
	Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device is assessed before sale is permitted.