Montpellier, December 3, 2019
An internationally recognized certification, ISO 13485: 2016, has been issued to REGEnLIFE which is developing an innovative technology for the Alzheimer’s disease by targeting the brain-gut axis.
REGEnLIFE, an innovative startup specializing in neurotechnology, announces that it has obtained its certificate of conformity to the ISO 13485: 2016 standard for the activity “Design and production of electromedical equipment used for neurological stimulation” from Kiwa Cermet, a notified organization.
REGEnLIFE’s Quality Management System is now recognized as meeting the standards specific to the development of its technology as a medical device dedicated to neurology. With this standard, which targets medical device companies, REGEnLIFE demonstrates its ability to meet the regulatory requirements of its suppliers and customers.
“This is a key milestone for our team as it highlights our resources and determination to meet regulatory requirements to ensure the safety and quality of our future medical products on market“. Says Guillaume Blivet, president and co-founder of REGEnLIFE.
Why ISO 13485: 2016?
The international standard ISO 13485 is the reference for the fulfillment of quality management approaches. It applies to the medical device design and manufacturing industries. This certification meets the regulatory requirements for medical devices and associated services of Regulation (EU) 2017/745 applicable in May 2020. In addition, this certification provides greater access to international markets.
REGEnLIFE is an innovative company developing a new therapeutic approach for neurodegenerative diseases. The startup goal is to bring to the world of health care a technology able to modify the progression of neurodegenerative diseases, to improve health and daily life of patients and to promote healthy aging. REGEnLIFE is currently developing a medical device dedicated to people with neurodegenerative diseases, particularly Alzheimer’s dementia. This medical device is currently in clinical evaluation at Montpellier University Hospital.