ISO 13485 is a standard that represents a set of requirements for the manufacturing, assembly, servicing, and sale of medical devices and equipment, and it is an essential requirement for placing medical devices and equipment on both local and EU markets.
The ISO 13485 standard is designed to facilitate the compliance of medical device manufacturers with laws and regulations, while also establishing and maintaining clearly defined processes during the implementation of a quality management system. ISO 13485 ensures the consistency of design, development, manufacturing, installation, and delivery of medical devices and equipment that are safe for their intended use.
ISO 13485 certification also includes the possibility of product certification in accordance with the EU Medical Device Directive 93/42/EEC. By obtaining ISO 13485 certification and product certification under the European Directive 93/42/EEC, complete compliance is achieved, enabling the unobstructed entry of products into the global market.
The ISO 13485 standard facilitates the alignment of the production, servicing, assembly, and sale of medical devices with laws and regulations, ensuring their seamless placement in the market.