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 report • Biocompatibility – BER, ISO 10993-1:2021 • Clinical evaluation – CEP, CER, literature search, vigilance search, references • Packaging and labelling information • Post-Market Surveillance (PMS) plan and report • Quality management system (QMS) compliance - ISO 13485:2016, ISO 9001