ISO 13485 certified

ISO 13485 certification guarantees high quality and safety

The main principle for any healthcare equipment and related services is that safety always comes first. The patient’s well-being is the top priority, which means that the equipment and services must function purposefully, without exceptions. For this reason, our sector has quality-related standards and systems that ensure the fulfilment of safety requirements in our products and services.

The development of the Medanets quality system started in 2008. From the very beginning, the goal was to implement the quality system as an integral part of our daily activities. In November 2010, VTT Technical Research Centre of Finland audited our quality system in line with the ISO 13485 standard. The most frequently used quality management standard in the world, ISO 13485 defines the quality requirements for medical devices and services related to such devices. Initially, the ISO 13485 standard was designed for the developers and manufacturers of medical devices. Medanets has also been able to successfully apply the standard to software development by involving all of our staff in the writing and development of our quality handbook.

Since 2010, our quality system has been updated and audited each year. In 2022, we selected Eurofins Expert Services as the certifying body of our quality system. We also plan to continue using their services in the near future for a product certification process in line with the Medical Devices Regulation (MDR) of the EU.

Thanks to the quality system, we can rely on the consistently high quality of our daily activities. The quality system helps us improve patient safety, minimise any risks related to our product and increase efficiency.

Our certified quality system helps us ensure that our product fulfils the official requirements and standards set for medical devices.  It guarantees that our product is safe for the patient and easy to use for the healthcare professional.

The essential parts of the quality system include handling risk management and customer feedback. Staff from different parts of Medanets participate in both risk management and the handling of customer feedback. As a result, any important information received from customer feedback, for example, is directly transferred to product development where the product can be further developed according to the end users’ wishes. Our product is part of societally important medical work. A customer-oriented approach forms the foundation for all of our development and the services related to the product.