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
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