We provide consultation for Medical and In-vitro Medical Device CE, US FDA, NIOSH, ISO, and Indian MDR certification along with services like Appointment of Authorized Representative, External testing services, EUDAMED registration, UDI Labelling, Registration on Sugam portal, Country registrations, Internal Audits, Management Review Meetings, Training, GAP analysis & audits, Mock audits, Conformity assessment, Document review, and Audit NC closures. For clients who face limited challenges in specific documentation, we also provide a customized service of preparing individual documents or parts of it. Our training & consulting support helps medical device customers to design & manufacture their products in compliance with regulatory requirements and bring them to the market more quickly, effectively & efficiently.
