Incereb Achieves ISO13485 Medical Device Certification (28th November 2014)

  • ISO13485 Medical Device Quality management systems (QMS) - Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard

Dublin based medical device start-up, Incereb Limited, has been certified under the ISO13485 Medical Device standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Paul Phillips, in his capacity as Incereb CTO and Regulatory Manager, guided the company toward this significant milestone following his appointment 12 months ago.

Incereb has developed disposable EEG testing (electroencephalogram used to detect abnormalities related to electrical activity of the brain) and Cerebral Function Monitoring (CFM) products for term and preterm infants (neonates) with seizures, in the neonatal intensive care unit (NICU). These products, developed for the neonatologist or neonatal nurse, will significantly speed up the time taken to set up the infant for testing and are designed to interface with all brands of EEG and CFM recording equipment.

Commenting on this achievement, Paul Phillips, said “ISO13485 Certification is the first step in bringing our product from being a lab based prototype to being a saleable medical device in the global market place. We have a wonderful team here at Incereb with a clear vision of where we want to go and what we need to do to get there – we will simplify the complex process of neonatal monitoring”.

About Incereb

Incereb is a venture funded Irish company – investors include ACT Venture Capital Limited, Delta Partners, the Boole Group and Enterprise Ireland (the Irish government organisation responsible for the development and growth of Irish enterprises in world markets).

The company was founded in 2012 by James Roche, CEO, to develop a simpler method of recording neonatal EEG, a traditionally time consuming and complex procedure with which he was very familiar having worked in hospitals in London, Glasgow and Dublin.