ALCEON MEDTECH CONSULTING

ALCEON MEDTECH CONSULTING specializes in Medical Device Consulting, Regulatory Affairs Consulting, and Quality Assurance Consulting. We offer expert guidance to navigate complex regulatory requirements, ensure compliance, and enhance product quality. Our e

"We provide regulatory consulting services to medical device and IVD device manufacturers Our Services - ISO 13485 - MDSAP - Process Validation - AMC - Audits - CE Certification - USFDA - CDSCO (Indian MDR) - Health Canada - Training - Clinical Writing - Clinical Trials - Risk Management & Usability - BER Writing - PMS & PMCF We have handled projects for over 50+ clients The projects include drafting complete technical files, designing and conducting clinical trials, helping with QA activities, and implementing Quality Management Systems. Have cumulatively handled over 100 projects worldwide A snippet of some of the projects handled is given on the following pages."