ISO 13485 – Medical devices

ISO 13485 sets out the requirements that organisations providing medical devices and related services must meet in order to comply with customer requirements and current regulations.

Organisations that can benefit from this standard are those involved in one or more stages of the life cycle of medical devices (design, development, production, storage, distribution, installation, technical support) or providing related services.

The processes required by ISO 13485 are incorporated into the organisation’s quality management system.

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