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Iso medical devices. 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. 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. Iso 13485 is the medical device industry s most widely used international standard for quality management. Standardization of the approach to biological and clinical evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.
What is the purpose of iso 13485. Information education and support for industry. 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. Iso 14971 2019 medical devices application of risk management to medical devices.
Being iso 13485 certification compliant shows a commitment to the safety and quality of your medical devices. Issued by the international organization for standardization iso the iso 13485 standard is an effective solution to meet the comprehensive requirements for a qms in the medical device industry. Buy this standard abstract preview. Safety communications recalls letters to health care providers reporting adverse events mdr and medsun.
Adopting iso 13485 provides a practical foundation for manufacturers to address the medical device directives regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. This document specifies terminology principles and a process for risk management of medical devices including software as a medical device and in vitro diagnostic medical devices. Assist sponsors investigators ethics committees regulatory authorities and other bodies involved in the conformity assessment of medical devices. Certification to iso 13485.
It can also be used by internal and external parties such as certification bodies to help them with their auditing processes. Note 1 users of this document need to consider whether other standards and or national requirements also apply to the investigational device s under consideration or the clinical investigation. The iso 13485 standard is an effective solution to meet the comprehensive requirements for a qms. Establish a risk based approach to product development and realization.
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