Kounter Intuitive Technologies

Founded in 2013, Kounter Intuitive Technologies (KIT) started its journey with the sole purpose of providing regulatory consultation to the medical device companies. We navigate the manufacturers through the complex landscape of getting regulatory approvals from their targeted regulatory authority. With a remarkable experience of 10 years, our team implements a highly customized approach and has the expertise in following standards: EU MDR 2017/745 IVDR 2017/746 FDA 21 CFR 820 UKCA SFDA DRAP Our services cover technical documentation of low-to-high risk (Class I III) medical devices. Comprehensive technical file Device design and manufacturing Verification and validation Risk management plan and...

Regulatory approvals,regulatory consultant,medical device regulations,qms compliance,technical documentation,iso 13485,iso 14971,iso 10993,iso 9001,eu mdr 2017/745 ,drap,ivdr 2017/746,sfda, fda 21 cfr 820,and ukca

Kounter intuitive technologies operates in the Legal services industry.

Kounter intuitive technologies's revenue is 11m - 100m

Kounter intuitive technologies has 11 - 50 employees.