What is ISO 13485?
ISO 13485 is an international standard which represents the requirements for a Quality Management System for companies which design and manufacture of Medical Devices.
It outlines the different aspects needed to be covered by the company’s QMS. Companies must apply this standard throughout their products’ life cycle, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.
It is recommended for a company to pursue ISO 13485 certification even before it begins manufacturing medical devices since certification is required by most international regulatory bodies, in particular the European regulatory requirements.