Ercé médical succeeds with ISO 13485 : 2016 certification
Ercé médical succeeds with ISO 13485 : 2016 certification
Ercé Médical is pleased to announce that he succeeds with ISO 13485 : 2016 certification.
Consequently, Ercé Médical is one of the first company to be certified with the new version of that standard, that will be soon the worldwide reference is the medical device business.
It’s most significant evolution of that standard since 2003. It is strictly reinforcing the risk management approach for patients and medical device users.
« We continue to raise the bar regarding quality and conformity, in the medical devices industry that is more and more demanding » indicates Sylvie Pinard, Quality Manger of Ercé Médical.
That 4 days audit was performed under the supervision of LNE-GMED.
« We are proud to continuously improve our culture of quality. It demonstrates our ability to be ahead of the competition » precises Franck Machurat, CEO of Ercé Médical.