ISO 13485 is a specialized standard for quality management systems. It is addressed to companies involved in any stage of the production of medical devices and to companies providing related services. In particular, it includes requirements related to the following processes:

• Design and development
• Production and inspections
• Storage and shipment
• Installation and technical support
• Planning and implementation of related services

It is applicable to businesses of all sizes and its requirements can be met by the company itself or by subcontractors who are appropriately monitored and controlled by the company. There is also the possibility of exceptions to specific chapters of the standard, if permitted by the applicable legislation.

ISO 13485 certification provides multiple benefits to the company. Indicatively:

• Global recognition in the medical device market.
• A clear and specific framework of requirements and specifications directly related to medical products.
• Alignment with the demanding and constantly evolving regulatory framework.
• An approach based on the potential risks related to the safety and performance of products.
• Methodology of optimal feedback processes for continuous monitoring and quality improvement of products.
• Sufficient documentation to support the submission of technical dossiers for medical devices to national or supranational licensing procedures (FDA approval, CE marking etc.).

Swiss Approval, accredited by the ESYD for this standard, has the required expertise and fully qualified staff to ensure the certification of any company in the field according to updated best practices.