Design Controls Programs

IQCDS has an extensive design control experience to solve the challenges that you encounter in medical device design control development. Our expertise and product portfolio spans throughout the medical device industry. Whether you are testing pacemakers or designing devices that will set up the next medical breakthrough, we provide the accuracy, reliability and performance you need to control your design process with confidence.

IQCDS’s consultants work with facility’s design control team, management at companies of virtually any size to assist them with their design control program. This can include starting and running the design control process for them on a fully outsourced basis or working with an existing design history file to supplement their team when they lack adequate staff or skills. IQCDS helps companies strengthen their design control process and manage complex medical device’s design history files.  In addition, IQCDS’s design control program and advisory team helps clients assess their compliance risks and implement solutions to better manage these risks. To discuss possible design controls improvements please contact us at (949) 235-6037 or email us at info@iqcds.com.