Obtaining certification for manufacturers of medical devices

On 03/03/2022. ML System has received certification for the Management System according to PN-EN ISO 13485: 2016-04, in accordance with the procedure of TÜV NORD Polska Sp. z o.o., which is an international standard for manufacturers of medical devices, demonstrating the compliance of their product with EU legal regulations. This standard introduces additional specific requirements (based on the requirements contained in ISO 9001), including concerning the structural construction, the production process and regime, as well as the requirements for the qualifications of the personnel responsible for the product.

The obtained certification confirms that ML System operates in accordance with the applicable directives and produces medical devices bearing in mind the safety and health of the tested people.