Expert and Global Leader in Flow Measurement em-tec GmbH to receive their first MDR certification.
em-tec GmbH ("em-tec"), Finning, is happy to announce that it has received the first MDR certification, laying the foundation for the successful transition from MDD to MDR certification.
As of 2017, the Medical Device Regulation 2017/745 (MDR) will gradually replace the formerly effective Medical Device Directive 93/42 EU/EWG (MDD). As a result, all medical devices must pass an MDR audit in order to retain their medical approval once the MDD certification loses its validity.
Being global leaders and experts for non-invasive flow measurements, the continuous improvement and development of their know-how and their products is an essential goal em-tec has set for itself and its staff. Consequently, a quick and seamless transition from MDD to MDR certification is among their top priorities.
"What makes it difficult is the fact that products already certified according to MDD must not be changed in any way since they would otherwise lose their certification. This limits em-tec's possibilities to improve products that are tried, tested, and established on the market," says Dr. Timo Lebold, Director Quality Management & Regulatory Affairs. As a result, a new certification is essential for em-tec's products in order to continue catering to their customers' needs and requirements especially in regard to safety and performance.
Thus, to ensure continuous progress and quality, em-tec is among the first manufacturers of medical devices to obtain MRD certification. Given the fact that the transition from MDD to MDR involves several hurdles in the form of new and additional prerequisites and documentation, em-tec is proud that their quality management and development department were able to make this process a smooth one. "With this certification, we have laid the foundation for a seamless transition to MDR. This affords planning security for us and our customers for the years to come while also granting security of supply with safe and top-performing products," explains Dr. Timo Lebold, Director Quality Management & Regulatory Affairs.
So far, the first products to pass the audit are the CLS (capacitive level sensor) and the LSP (level sensor pad), but other products will, of course, follow soon. The CLS and the LSP are independent accessory parts for the isolated and contact-free fill level recognition of reservoirs containing liquids in extracorporeal circuits.
For over 30 years, em-tec GmbH has been developing and manufacturing innovative and economical products and customer-specific solutions for medical as well as non-medical applications on-site in Finning, Germany. The main focus so far has been on life-sustaining devices, especially in the field of heart surgery or cardiac support systems. One of the core competences is the non-invasive flow measurement, using the ultrasonic transit-time method. Based on this technology, em-tec offers products and components for medical and non-medical applications such as cardiac or vascular surgery, for applications in laboratories, for bio processes or other industrial applications that use flexible tubes.
em-tec GmbH · Lerchenberg 20 · 86923 Finning · 08806 92 36 35 · www.em-tec.de