As EU MDR has already entered into force and will be applicable in May 2020,the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence.
Unique Device Identification (UDI) is intended to assign a unique identifier to medical devices within the United States it marks and identifies individual medical devices throughout their distribution and product life.
First Time Right Filing June 2016
Many large and medium biopharma companies operate in 100+ countries. It’s highly challenging to meet regulatory requirements for product approval of new and generic drug fillings, assuring regulatory compliance, and maintaining lifecycle of regulatory authorizations and established guidelines in these countries.
Page 2 of 8