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.