-Brief Overview of ‘How to bring a Medical Device into market??
-
Where Do I Start?
-From Ideation, Market research, Finance, Design Development, -Design Control, Design Transfer, DHF
-QMS, Reg Submissions, till Product launch
-Regulatory Plan/Regulatory Strategies [US, EU, INDIA
]
-QMS Implementation
-Quality & Culture
-How can we be Quality compliant-ALL THE TIME?
-Responsibilities for each Employee
-Risk Management
-Post Marketing Surveillence [PMS]
-External Audits/Inspections
-INDIAN REGULATION/MAKE IN INDIA
-MDR-2017
Thanks,
Rajashri Ojha
Founder & Director
#medicalcollege #medicaldevice #qualityassurance #biomedicalengineer #opportunities #development #marketresearch #medical #design #qualityassurance #regulatoryaffairs #qualitycontrol #medicaldevices #mechanicalengineering #mdr #eumdr #fda #submissions #learninganddevelopment #elearning #trainingandplacement