Movesense has been granted ISO 13485:2016 Quality System Certificate
We are extremely excited to announce that Movesense Ltd has been granted ISO 13485:2016 medical device quality management system certificate. The quality management system of Movesense was audited and certified by Eurofins Electric & Electronics Finland Ltd.
ISO 13485:2016 standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device. The Movesense medical QMS certification covers the following functions and/or services of Movesense Ltd: design, development, production, final inspection, sales and distribution of wearable medical sensors and accessories.
“This is an important milestone and a major achievement for Movesense Ltd and the whole team. The QMS certification strengthens our position and allows us to expand our offering as the leading OEM ECG and motion sensor solution supplier. Our certified ISO 13485 quality management system is a proof of our ability to produce high quality medical sensor products that meet the strict regulatory requirements and fulfill the needs of our global customer base – including medical device customers operating in Europe under MDR/MDD, as well as for example our U.S. customers working on the FDA clearance of their Movesense MD based patient monitoring solutions”, says Jussi Kaasinen, CEO and Founder of Movesense.
Movesense is very proud of its team of professionals who has all the necessary knowledge and skills covering the entire product lifecycle process of demanding medical equipment.