Medical Devices – ISO 13485

Regulatory standards are becoming more strict throughout every phase of a product’s life cycle,
including servicing and delivery. As a result, organisations in the sector are being put under more
and more pressure to show off their quality management procedures and guarantee top practices
in everything they do. This internationally agreed standard sets out the requirements for a quality
management system specific to the medical devices industry.

ISO 13485 specifies requirements an organisation must be able to supply medical devices
and related services that consistently meet the needs of the customer and any applicable
regulatory requirements.

One or more steps of the life cycle, such as the design and development, production, storage,
distribution, installation, or maintenance of a medical device, as well as the design and
development or provision of related operations, can be included by such companies (e.g.
technical support). In addition, suppliers and other outside parties who deliver goods to these
organisations, including services connected to their quality management systems, are likewise
permitted to adopt ISO 13485.

ISO 13485 has already been tested and proven as the global benchmark for Quality Management
Systems in the medical device sector. Companies that have received certification can
demonstrate to prospective customers that they adhere to regulatory regulations and best
practises. Additionally, as a result of ongoing development and better process control, your
business will inevitably experience increased ROI.

Like other ISO management system standards, ISO 13485 does not mandate certification, and
businesses can still implement the standard and enjoy many benefits without going through the
certification process. However, third-party certification can show regulators that you have
complied with the standard’s requirements. The ISO doesn’t carry out certification.