Karthika Sankar Email and Phone Number

Experienced as a regulatory analyst in,EU - MDR gap assessment, technical documents preparation for medical products, also standard gap assessment for standards such as ISO 13485, ISO 14971, ISO 62366 etc.,ASEAN medical device directive (AMDD) for member states such as Thailand, Malaysia, Singapore, Philippines and Vietnam for performing gap assessment and dossier preparation for medical devices.China NMPA regulations for medical devices.US FDA 510k pathway gap assessment and guidance gap assessment for medical devices. Having knowledge in various country regulations like Hong Kong, India and Thailand