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Iso 13485 medical devices quality management systems requirements for regulatory purposes is the international standard for quality management systems for the medical devices sector published in 2016 it is designed to work with other management systems in a way that is efficient and transparent.
Iso standards for medical devices. 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. A medical device is a product such as an instrument machine implant or in vitro reagent that is intended for use in the diagnosis prevention and treatment of diseases or other medical conditions. This article explains the method starting with standards from the international organization for standardization iso adopted and recognized in various regulatory systems. This standard has been revised by iso 14155 2020 abstract iso 14155 2011 addresses good clinical practice for the design conduct recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
Detailed guidance to optimize its use has just been updated. The iso 13485 standard was entitled quality systems medical devices supplementary requirements to iso 9001. Whereas iso 9001 emphasizes continual improvement and customer satisfaction 13485 encompasses the requirements that medical device manufacturers must incorporate into their management systems. Medical device standards supported by nqa.
The article uses iso 13485 2003 and iso 14971 2007 as illustrations p. Reducing and managing risks related to medical devices is the objective of a key industry standard iso 14971. Several management standards are applicable to medical device manufacturing. Who is iso 13485 for.
Read on for a brief overview of the most relevant as well as information about the role nqa can play in getting your organization certified. The standard which is now in its third edition received strong support from the fda. P one common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards. Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization iso standard published for the first time in 1996.
The most common medical device manufacturing standards include. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices this standard supersedes earlier documents such as en 46001 1993.
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