Publication date: 21.05.2025r.
MyWam Sp. z o.o. has implemented and consistently maintains a quality management system in accordance with the requirements of the ISO 13485 standard, covering the design, manufacture and sale of Class I medical devices. Certification granted by LL-C (Certification) confirms that all processes related to the creation of our products are carried out in a controlled, documented manner and in compliance with international standards.
In practice, this means, among others, precise definition of work stages, supervision of key processes, and the use of methods ensuring user safety.
Each product, before being placed on the market, undergoes a conformity assessment procedure and receives full technical documentation and CE marking. We also monitor the performance of our products after their implementation in order to respond to user needs and continuously increase the reliability of the offered solutions.
The ISO 13485 system supports us in maintaining transparency of activities, effective control methods and continuous process improvement. For us, it is not only a formal requirement, but above all a commitment to responsible action and to delivering equipment that meets high quality and safety standards.
Safety based on standards.
