Certification Program - Medical Device Regulatory Affairs

This course is specifically focused on the law, regulations and policies set by the regulatory bodies for the pre-market approval, manufacture and post-marketing compliance of medical devices. (US, EU)The course content is designed to provide an in-depth understanding of the ways to obtain the agency approvalIt also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspectionsTopics CoveredToptopWhat are Medical Devices?Classification of Medical devices - USA- Europe- IndiaExporting & Registeration of Medical devices - USA- Europe- India510k SubmissionCE MarkingQMS & ISO for Medical DevicesLabelling of Medical DevicesWho Should Apply
Medical Device ManufacturersRegulatory Affairs ProfessionalsPeople Involved in Product Design,Research & DevelopmentQuality Assurance & Quality Control PeopleMedical/Marketing Personnel Involved in Medical Device