Class A
Minimal risk
Blood pressure cuffs, scissors, etc.
Class B
Love to Moderate risk
-
Class C
Moderate to High risk
Implantable devices/devices
Class C
Highest risk
-
Valued at US $2 Billion (est.)
Growing at a CAGR of 7.5%
60% of the World’s Medical Gloves 80% of Catheters Manufactured
95% Medical Devices Imported
Summary of Medical Device
Information related to the Manufacturer of Device
Device Classification
CSDT
Post Market Surveillance Data
Declaration of Conformity
Attestation of Medical Device
Marketing Authorization Holder (MAH) Services
Gap Analysis
Regulatory Intelligence and Strategy
Technical File Preparation and Submission
Clinical Evaluation and Post Marketing Evaluation
Response to Queries
Audit Support
Quality Training
Quality Management System Implementation
Regulatory Affairs
MCSE boot camps have its supporters and its detractors. Some people do not understand
Quality Management
MCSE boot camps have its supporters and its detractors. Some people do not understand
Market Access
MCSE boot camps have its supporters and its detractors. Some people do not understand
Regulatory Affairs
MCSE boot camps have its supporters and its detractors. Some people do not understand
Quality Management
MCSE boot camps have its supporters and its detractors. Some people do not understand
