Iso Certification For Medical Devices

The current iso 13485 edition was published on 1 ma.

Iso certification for medical devices.

For medical devices the applicable international standard is iso 13485 2003. It can also be used by internal and external parties such as certification bodies to help them with their auditing processes. Further link has been changed for this information. A medical device is a product such as an instrument machine implant or in vitriol reagent that is intended for use in the diagnosis prevention and treatment of diseases or other medical conditions.

Please click on the following link. Iso 13485 2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization standard published for the first time in 1996.

The quality management standard iso 13485 2016 was published to support medical device manufacturers designers suppliers and other interested organization in building designing and implementing quality management systems in order to ensure sustainable effectiveness of their processes. Being iso 13485 certification compliant shows a commitment to the safety and quality of your medical devices. Design and manufacture of medical devices. Requirements of iso 13485 are applicable to organisations regardless of their size and regardless of their type except where explicitly stated.

Iso 13485 2016 thanks for contacting to tnv. Iso 9001 is a general quality management system standard and iso 9001 2008 is the most recent revision. This standard supersedes earlier documents such as en 46001 and en 46002 the previously published iso 13485 and iso 13488. Iso 13845 is beneficial for many organisations and can be used by suppliers and external parties that are involved with providing medical device products.

Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical devices and related services. The certification iso 13485 medical devices quality management systems identifies a standard for the quality management system specific for companies in the medical sector that includes aspects of the iso 9001 standard and specific requirements for medical devices and in vitro diagnostic medical devices sector. Establish a risk based approach to product development and realization. The advantages and dangers of focusing too much on iso certification are also reviewed.