23 June 2021
Injeq quality management system is now MDR 2017/745 and ISO 13485 certified
According to the Medical Device Regulation 2017/745 (MDR) all medical device manufacturers must have a Quality Management System. Injeq Oy has received the certification of its Quality Management System (QMS) according to the EN ISO 13485:2016. Also, the QMS certification according to the Medical Device Regulation was received for Injeq class I and IIa medical devices.
These certificates are a key achievement in confirming Injeq as a medical device manufacturer. They are an important step towards completing the ongoing CE marking process of the products and the first IQ-Tip® system, including Injeq class III medical devices.
MDR is the applied regulation within the European Union for medical devices. As the new MDR is considered one of the most stringent regulatory requirements in the medical device industry, it is a substantial achievement to document the compliance of the company processes. Since May 2021, all medical device products seeking regulatory approval in Europe must conform to the MDR. By confirming that the company Quality Management System meets the regulations, Injeq continues to move forward in CE marking of the products. The certification and Notified Body TÜV SÜD Product Service GmbH has assessed and audited Injeq quality management system and processes.
According to Jussi Seitsonen, Head of Quality, Injeq has achieved an important milestone: “We are extremely pleased with the ISO 13485 certification. Our QMS has already been audited in accordance with the new EU Medical Device Regulation. We are steadily moving towards the CE mark and European marketing authorization for our first system.”
Injeq in brief
Injeq is developing intelligent medical technology for demanding lumbar punctures and medical injections. The leading product under development is the IQ-Tip® system, which is a novel method for demanding lumbar punctures. The clinical performance and safety of Injeq IQ-Tip® system have already been evaluated in three clinical trials in university hospitals. The smart needle system is feasible for lumbar punctures from neonates to older adults, including treatment punctures of children with leukemia. The company operates in Finland and is aiming towards European and global markets. Injeq currently employs 16 professionals and is commercializing its first products. Injeq is supported by a strong team of experienced medical experts and broad scientific research.