Myocene Awarded ISO 13485 Certification

Myocene has achieved ISO 13485 certification for its quality management system.
 
The Belgian startup has developed a device for objectifying and measuring muscle fatigue, targeting top-level athletes. The ISO 13845 standard sets forth the requirements of a quality management system for medical devices. Upon a Notified Body inspection of its quality system, 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,” CEO Jean-Yves Mignolet said. “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 U.S. market access, as ISO 13485 represents a good basis for FDA’s Good Manufacturing Practice requirements.”
 
The Myocene device, designed for top-level athletes, represents a significant achievement in sports, according to Myocene. 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, traditionally there has been no way of measuring it objectively, accurately, and quickly. In this respect, the Myocene device enables 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.

Myocene’s muscle fatigue measuring device has been tested on nearly 1,000 athletes. Last fall, the company signed a contract to supply its patented technology to France’s top-flight professional football club, OGC Nice. The club will use Myocene’s technology during training sessions and matches to optimize players’ performance; players will undergo weekly muscle fatigue measurements throughout the season to assess their recovery levels, and their general condition after each match. The team’s fitness coaches can use this information to decide when players are ready to return to training ahead of upcoming matches. Similarly, the club intends to use the device to monitor players recovering from injuries and determine whether they are able to return to high-intensity training.

“We chose Myocene’s device as a tool that allows us to reliably assess the players’ ‘freshness’ and recovery levels,” Laurent Bessiere, performance director at OGC Nice, explained upon signing the contract agreement.

Several other teams are using Myocene’s muscle fatigure measuring device technology as well, including French handball clubs Saint-Raphaël Var Handball (SRVHB) and US Ivry, and the French and Portuguese football clubs RC Strasbourg and Sporting Clube de Braga. 
 
Myocene creates unique and innovative devices for measuring muscle fatigue and performance using patented algorithms and artificial intelligence.