ISO 13485:2016 Certification

ISO 13485:2012 is the globally recognized standard for the best quality management systems in the medical device industry. It specifies the top requirements for a quality management system where an organization needs to demonstrate its capability to provide medical devices and related services that consistently meet client needs and applicable regulatory requirements. It is designed and planned for use by organizations involved in the design, development, production, installation, servicing, and sales of medical devices.

There are many top standards of conformity that must be complied with by manufacturers of medical devices to ensure the delivery of only the best quality products to clients. Regulatory agencies are very strict in enforcing these standards in the medical manufacturing sector, as these products are directly connected to the health and safety of clients. ISO 13485:2012 is one such best standard that must be adhered to by manufacturers of medical products and devices to ensure the highest level of safety and health for clients. It is a set of top instructions that must be followed by manufacturers to maintain the best level of quality, along with continual improvement. The ISO 13485:2012 certification is designed to provide sufficient information about the key requirements for an efficient and effective quality management system that can be utilized for designing, developing, manufacturing, and marketing medical products.

Benefits of ISO 13485:2012:
– Outline the best practices to review and improve procedures across your organization.
– Meet top regulatory requirements and client expectations.
– Enhanced access to more international markets with certification.
– Demonstrate that you produce safer and more effective medical devices.
– Increase efficiency, cut costs, and monitor supply chain performance to the best standards.