ISO 13485 Medical Devices

Today’s competitive business environment has placed tremendous pressure on medical devices manufacturing companies to lower operating costs, address complex product design, outsource development and seek global expansion plans. Beyond this pressure there is major opportunity for companies to build a competitive advantage through an integrated risk and compliance management approach that ensures all features are working together effectively, enabling superior visibility into the value chain.

Medical Devices manufacturing processes and supply chain management that were once easy to handle are now much more complex. What used to be controlled and contained within the manufacturing plant is now monitored, run and maintained globally. Given this situation, building an effective risk and quality compliance system that conforms to management standards like ISO 13485 and ISO 9000 among others, is imperative for companies that want to work efficiently and succeed over smarter customers.

ISO 13485 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 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9000 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems follows all the requirements of ISO 9001. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization