Senzimes TetraGraph system and new manufacturing facility certified against MDR

Pressrelease: Uppsala, on 6 December 2021. Senzime today announces that the company’s products, quality system and manufacturing facility has been certified in accordance with the new European Medical Device Regulation (MDR).

Since May 2021, the European Medical Devices Regulation 2017/745 (MDR) is applicable in Europe, replacing the Medical Devices Directive (93/42/EEC) and introducing major changes to how medical device manufacturers obtain European market access. This transition involves an increased work effort compared to the MDD, since the MDR introduces a life-cycle approach for the CE Marking Compliance and introduces many new requirements.

Senzime early identified this as an important process, establishing a transition plan with focus on identifying the gaps between the current and new regulation. By meeting the quality, regulatory and domain specific requirements during the product life cycle through an effective and practical QMS and procedures, as well as well-adapted product testing and documentation, we maintain our competitive edge.

Pia Renaudin, CEO of Senzime, says: “Safety and effectiveness are focus areas for us. A deep understanding and knowledge of continuously changing regulations and standards is imperative to our regulatory roadmap, and I am so proud to have our team deliver on this important milestone.”

Senzime was founded in Uppsala in 1999 and the company’s shares are traded on Nasdaq Stockholm main market (ticker SEZI).

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