Monarch Bioimplants receives ISO 13485 certificate
Effective on 18th of October 2019, Monarch Bioimplants has been issued the important ISO 13485:2016 certificate by the Notified Body BSI which justifies that the company has established a quality management system in compliance with the requirements of the internationally recognized standard for medical device manufacturers.
The ISO 13485:2016 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The ISO 13485 certificate is a fundamental step in the development of our company towards a significant player in the nerve repair market commented Dr. Rivelino Montenegro, CEO of Monarch Bioimplants. Following the recent FDA clearance for our lead device NeuroShield, the ISO 13485 certificate will allow us to complete the CE process for market authorization in Europe.