POISE Medical R.A. Consultants
The High Road to Service is travelled with Integrity, Compassion and Understanding.
Because people don't care how much we know;
Until they know how much we care.
24+
Years of Experience
15
Current Projects
3
Easy steps to start
900+
Audits as N.B. Auditor
900+
Happy Clients
17
Global Experience (Countries)
About Us
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 of the New MDR May 2017/745 has passed, although there have been new devloppments on the new timelines of the implimentation of the new regulation. Still it is challenging us to employ a set of quality compliance standards much higher than ever before.
