Medical Devices & IVDs

The medical device industry encompasses a wide variety of products including In Vitro Diagnostics. The Medicines Control Council has issued 5 guidelines that relate to the regulations published on 9 December 2016 and qualify the compliance expectations.

We can assist with the following:

  • Product classifications
  • Creation of Site Master Files
  • Design and Implementation of Quality Management Systems
  • Development and Implementation of Standard Operating Procedures
  • Collation of Standard Technical Documents
  • Review of Labels and IFUs


© 2019 MRA Regulary Consultants | All rights reserved