ISO 13485 Certification in Kolkata

Listing ID #1109629

ISO 13485:2018 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 requirements and regulatory requirements applicable to medical devices and related services.the primary objective of iso 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.all requirements of iso 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.if regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with iso 13485:2018 reflect exclusion of design and development controls. The processes required by iso 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system. advantages of iso 13485 certification: as we mentioned, iso 13485 certification is not mandatory in most markets. Here is how your company can benefit from iso 13485:2018 certification:- • compliance with european standards offers straightforward access to the japanese, australian and new zealand markets • other countries around the world also recognize iso 13485 as a means of meeting their quality requirements • iso 13485 is a globally recognized standard and having this certification will increase the credibility of your company with potential customers. • certification can lead to increased efficiency, better product quality, and improved customer service within your company • demonstrate your consumers and partners a commitment to quality the iso 13485 standard, officially named en iso 13485:2018, can be used by organizations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements. In europe, iso 13485 (or en iso 13485) is seen as the de facto standard for the medical device industry. Based on the broader iso 9001 standard, iso 13485 was first implemented in europe in 1996. Although iso 13485 certification is voluntary, obtaining certification allows you to meet the quality system requirements of the european medical device directive (93/42/eec), in vitro medical device directive (98/79/ec) and active implantable medical device directive (90/835/eec) with less difficulty. What are the 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 if regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with iso 13485:2003 reflect exclusion of design and development controls. The medical devices regulations require class ii, iii and iv medical devices to be manufactured (class ii) or designed and manufactured (class iii & iv) under can/csa iso 13485:2018.