UNE-EN ISO 13485

Who is it for?

The UNE-EN ISO 13485 standard is addressed to medical devices manufacturers, to its distributors or to the product technical assistance services, such as electromedicine services or sterilization centres. It also extends to all those products and health services that the company does not carry out, but of which it is responsible.

Benefits

• The certification allows to increase the quality of the sanitary service that is provided.
• In many cases, the certification is the previous step to comply with the requirements established by legislation to commercialise or handle medical devices.
• It makes customers trust the company as they are assured that the products/services are in accordance with applicable laws.
• This standard gives complete control over production and ensures a correct delivery to the customer without losing quality throughout the process.
• The quality management of the organisation is formally and publicly recognised.