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Infermedica achieves ISO:13485 certification

Infermedica, driven by a constant desire to improve and provide a better quality of its healthcare solutions, has undertaken a thorough auditing process. The result is ISO:13485 certification confirming the highest standards for Infermedica's chosen quality management systems.

ISO 13485:2016 is the internationally recognized gold standard for quality in the medical device industry.
ISO 13485:2016 is the internationally recognized gold standard for quality in the medical device industry. Illustration by Aga Więckowska.

What is ISO:13485?

ISO 13485:2016 is the internationally recognized gold standard for quality in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Organizations covered by this certification must be involved in one or more stages of the solution’s life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device, as well as design and development or the provision of associated activities (e.g. technical support).

In the case of Infermedica, it is: design, development, production, sales, and the service of stand-alone software for preliminary medical diagnostic support.  A variety of solutions are available within the Infermedica platform.

Improvements driven by ISO:13485

“ISO:13485 was created to support medical device manufacturers like Infermedica in designing a quality management system that establishes and maintains the effectiveness of the processes,” comments Marta Kuźnicka, Medical Device Regulatory Manager at Infermedica. Prior to the certification process, Infermedica verified and improved all its internal procedures. “The certification of the system ensures the consistent design, development, production, installation, and delivery of Infermedica’s products that are safe for their intended purpose”, adds Marta Kuźnicka.

The audit process was preceded by the authorized auditor, representing the TÜV Nord Notified Body.

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Infermedica’s plans for the next certifications

On its way to prove the safety and reliability of its solutions, Infermedica is also proceeding with other certifications. This includes an application for ISO:27001 and changes in Medical Devices Regulation (MDR). Currently, Infermedica is classified as medical device class I, but soon it will advance to medical device class IIA. The change is related to the risk for the end-users of solutions and, consequently, the higher standards that solution providers must fulfill. The future MDR certification will increase the safety level of Infermedica solutions and strengthen the level of credibility of its Software Medical Devices.

Check the dedicated information about MDR for Infermedica API users.

"To comply with MDR, all Infermedica’s medical devices need to be classified appropriately, and all technical documentation and evidence of compliance need to be available,” comments Marta Kuźnicka. “We have already developed the necessary systems to handle clinical evaluation, quality management, post-market surveillance, and liability for defective devices. It will assure our clients that by buying the licence from Infermedica, they buy the highest quality standard product that is safe for their users. The MDR certification will increase Infermedica's customer confidence and  competitiveness in the domestic and foreign markets," adds Marta.

The change of MDR classification has started on May 26th, 2021, as permitted by the Council Regulation 2017/745 of April 5th, 2017, on Medical Devices.  

For more information, please get in touch with us.

BL/EN/2021/06/15/1