Dignitana is certified under ISO 13485 and the company’s products are FDA cleared and CE certified as class II a.

Dignitana Quality Policy
All employees of Dignitana are responsible – within his/her area of responsibility and authority – to assure that our products and services meet customer and regulatory requirements and expectations.

Customer satisfaction is important, and each product or service is an excellent reference for further sales. Non-conforming products and procedures and customer complaints are analyzed and used for improvement.

Dignitana’s success depends on the scalp-cooling technology and its correct usage. Training of Dignitana employees and end users is crucial.

Dignitana relies on contract manufacturers and suppliers to deliver high quality products. Therefore, Dignitana provides clear requirements in contracts and purchase information.

Dignitana’s Quality Management System provides information of our planned processes, procedures and activities. Dignitana measures and monitors the system, and the information is used to detect, make correction and to prevent errors and non-conformities.

Dignitana will provide sufficient resources for the effective operation and maintenance of the Quality Management System.

CE Certificate

ISO 13485:2016 Certificate (Dallas, Texas, United States)

ISO 13485:2016 Certificate (Sweden)