Manikandan Palani

Mdr Vigilance Specialist at Medtronic @美敦力

Hyderabad, IN

Supports complaint handling for medical devices and vigilance activities.*Electronic documents management (GCH- Global complaint Handling tool) and SAP.*Timely complaint closure and regulatory reporting.*Root cause investigation and CAPA for late regulatory reports.*Adherence to quality standards and regulations of Medtronic.*Support regulatory inquiries from USFDA, Health Canada, ANVISA and EU regulatory authorities.*Implementation of 21 CFR part 820 and ISO 13485.