MEDIcept Insights

Guidance on IVDR Significant Changes

Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...

New Unique Device Identifier Deadline Approaches

A Unique Device Identifier (UDI) is a numeric or alphanumeric code that is assigned to a medical device. These codes are entirely unique, designed as a method to easily identify and determine the use of devices sold in the United States and Europe. The purpose of a...

Think about package validation early in product development

Some medical device manufacturers may not start to consider package validation testing until they’re already far down the road in device design and development. If so, they could be losing time, money, and market opportunity as a result of shoddy or incomplete testing...