POISE Medical R.A. Limited specialises in all regulatory affairs related to medical devices. We provide cost effective solutions for Compliance to all applicable regulatory standards including, but not limited to, ISO 13485:2016, 9001:2015, new MDR 2017/745 and MDSAP - supporting your product through the entirety of its lifecycle on the market.

The current regulatory environment for Medical Devices is developing at an unprecedented rate. The deadlines to implement ISO 9001:2015 and ISO 13485:2016 have already passed. The New MDR May 2017 is here and is challenging us to employ a set of quality compliance standards much higher than ever before.