Myocene Got ISO 13485 Medical-Grade Certification

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LIÈGE, Belgium, Feb. 13, 2024 (GLOBE NEWSWIRE) — Myocene, the Belgian-based sportstech company, has successfully obtained from a Notified Body the ISO 13485 certification for its quality management system.

Myocene is a Liège-based start-up that has developed a device for objectifying and measuring muscle fatigue, targeting top-level athletes. Since the creation in 2020, emphasis has been put in using rigorous and structure procedures in the development, validation, manufacturing and commercialization of its product. The ISO 13845 standard sets forth the requirements of a quality management system for medical device. Following external audits by a notified body, who inspected in details the quality system in place in the company, Myocene received a certificate for the design, development, production, sales and distribution of Muscular Fatigue Measuring Devices.

“This represents an important step for the company,” says CEO Jean-Yves Mignolet. “On the one side it increases the credibility of our products, as it proves they are designed and manufactured according to the highest standards of quality. On the other side, this paves the way to US market access, as ISO 13485 represents a good basis for FDA’s Good Manufacturing Practice requirements.”

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The Myocene device, designed for top-level athletes, represents a veritable revolution in the world of sport. Muscular fatigue is a fundamental parameter closely linked to sporting performance. Despite the major importance of muscular fatigue and the wealth of scientific knowledge on the subject, until now there has been no way of measuring it objectively, accurately and quickly. In this respect, the Myocene device represents a major step forward, enabling elite athletes to better design their training, avoid overtraining and reduce accidents linked to the loss of strength and speed secondary to long-term muscular fatigue.

With this certification step achieved, Myocene will continue to improve its technology and product, including implementation of cloud synchronization and analysis of data, and setting up of specific use protocol per sport.

About Myocene
Myocene® is a Liège-based sports technology company which creates unique and innovative devices for measuring muscle fatigue and performance. Thanks to patented algorithms and AI, the Myocene measurement represents a real breakthrough for athletes.

Learn more about Myocene by visiting www.myocene.com, and following us on Instagram (https://www.instagram.com/myocene.sport.technology/), Facebook (https://www.facebook.com/MyoceneSportTechnology) and YouTube (https://www.youtube.com/@myocene.sport.technology).

CONTACT: Media contact Myocene Jean-Yves Mignolet, CEO [email protected]

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