ISO 13485:2013 ConsultantsISO 13485:2013
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). The ISO 13485:2013 Standard is based on the UNE-EN-ISO 9001:2000 Standard and lists the requirements for a quality management system to be used by an organization in the design, development, production and installation of health products and the provision of services related to them. Using health products that comply with this standard help enhance the quality of the healthcare provided.
It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.
Benefits of ISO 13485 Medical Devices?
Increase access to more markets worldwide with certification.
Outline how to review and improve processes across your organization.
Increase efficiency, cut costs and monitor supply chain performance.
Demonstrate that you produce safer and more effective medical devices.
Meet regulatory requirements and customer expectations.
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