The EU’s new Medical Device Regulation (MDR) will enter into force on 26 May 2021. The MDR sets new requirements also on the Medanets solution, but worry not: we are well prepared. We ensure the quality and safety of our product with the ISO 13485 quality management system and the fulfillment of the MDR requirements.
The Medanets solution is a medical device. For a medical device manufacturer, it is important to ensure the quality of the product’s development process. The product must be fit and safe for use. This can be achieved by establishing an adequate quality management system. Certain documentation needs to be generated during the product development process to ensure that the product meets the essential requirements of the Medical Devices Directive (MDD) and the MDR, and can be CE marked. The CE mark guarantees a safe, high-quality product and is also a common requirement in public tendering. The Medanets solution is CE-marked.
Medanets has had a certified quality system ISO 13485 in place since 2010, which means that we have been systematically developing our quality for over a decade!
Quality and regulatory requirements for medical devices are increasing
The new regulation requires slightly more from the quality management system than the ISO 13485 standard. If a manufacturer has not had a quality system before, the requirements of the MDR may come as a surprise and require a lot of work. The upcoming regulation may even remove some software classified as medical devices from the market if their manufacturer is not prepared to comply with the MDR requirements.
At Medanets, we have started integrating the new requirements into our quality management system already a couple of years back. This work has been based on our strong ISO 13485 quality system. By preparing, we ensure that our customers can confidently acquire and use the Medanets solution, and partners can integrate it to their Electronic Health Records.
The development of the quality system and compliance with the changing regulatory requirements need continuous work. That’s why we recruited Tiina Kotipalo, one of the Finland’s leading medical device quality specialists, to join us.
We take care of our product throughout its lifecycle
The most important phase in the lifecycle of a medical device is product development, where the safety and functionality are built into the product. The applicable harmonized standards, such as the Medical Device Software Lifecycle Standard (EN 62304), the Medical Device Usability Standard (EN 62366), and the Medical Device Risk Management Standard (EN ISO 14971), have been baked into our product early on in its development process. The standards are applied continuously in the day-to-day development work. This helps to improve the quality of the software and reduce risks in the final product.
The responsibility of a medical device manufacturer covers the entire lifecycle of the product, from its design to the removal of the product from the market. The lifecycle also includes reliable support for the customers, as well as, for example, appropriate incident reports and corrective actions whenever needed. We collect information about the operation of the Medanets solution in cooperation with our customers and make sure that the product works as intended, helping healthcare professionals in their work.
For us, it is a matter of honour that the users are satisfied with our product and can rely on its operation.
Changes to medical device classifications
In accordance with the MDR, the Medanets solution will rise from a class I product under the MDD to a higher class II under the MDR. The product will be certified accordingly.
Although the classification changes, the changes to the Medanets product itself are small – mainly new markings and clarifications to documents, such as instructions for use. For the end users of our product, these changes will not be visible, and they can continue its use like they have done before.
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