DNV GL Approved Indian MDR Workshop

2 day workshop

OBJECTIVES: 

  • Indian Medical Devices Rules 017 regulatory requirements
  • Risk based Classification of Medical Devices and Guidelines
  • IMDR Fifth and Fourth Schedule
  • Requirements of performing clinical investigation in India
  • Latest amendments in MDR 2017
  • Post Approval requirement of Import / Manufacturing License
  • Purpose and requirements from an auditing perspective
  • What is an audit and why are they necessary
  • How to plan & conduct audits