Dhanasekar Selvaraj Email and Phone Number

Having demonstrated experience in EU Medical Device Regulation (EU MDR 2017/745), Product Standard compliance for Medical devices in terms of Packaging (ISO 11607), Labelling (ISO 15223-1, ISO 20417), Biocompatibility and knowledge on ISO 14971, DHF with good customer handling exposure, ISO 13485 experience, sterilization, design control, verification and validation, Experience in MDR conformity assessment, 21 CFR 820, change control management, leading team.