Ways to Ensure Smooth Design Transfer Process

Design Control is an important part of the medical device design & development. To control the design and development of a medical device, regulations have been developed by regulatory bodies such as USFDA, European Commission, and others. These regulations are known as “Design Control.”

Following are the steps Smooth Design Transfer Process

· Plan Early

· Follow Requirements

· Take Time

· Select a Manufacturer

· Document as You Go

Design control is a set of procedures and practices applied to the design activity intended to ensure that the output product meets the input requirements. It includes understanding user needs, and requirements and thereafter designing a medical device to meet those requirements along with risk analysis. Control also includes the evaluation of the medical device and transferring it to the production line for manufacturing.

IZiel Healthcare can further support you in preparing a complete Design History File (DHF) or Technical File starting from understanding user needs, requirements writing, requirements management and, verifying and validating user needs until design transfer.