Risk Management

From design, to engineering, to testing, and beyond, your risk management process is an integral part for any phase of the project. Our engineering methodologies are optimized to keep expenses low and design times down. We know how to minimize the total duration of the project to maximize your return on investment.

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Risk Management

DHF Remediation Service

Sterling will help create a well-established, formal, Design Control process will ensure that the DHF contains all of the records required by the FDA. As the FDA medical device regulatory requirements and as you update your Quality System, it is important to ensure that design history files for legacy products are compliant to the new standards.

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DHF Remediation Service


Sterling understands that Quality Systems and how they are practiced are paramount in medical device development and ultimately in obtaining medical regulatory compliance.

Quality System

Sterling’s FDA compliant processes provide clients guidance through complexity to achieve a successful medical device that sets the bar for high quality in the industry.


As technology becomes increasingly mobile and our devices more connected than ever, the risk of network breaches increases as well. Sterling guides clients through a stringent cybercecurity process to secure devices.

Polarion Consulting

Sterling offers Polarion Consulting to help clients document their projects and services more efficiently. This consulting includes helping clients customize Polarion software so that it works in the most efficient way for their line of work.

Tool Validation

Sterling Medical Devices is equipped with different methods of medical device tool validation which gives our team the opportunity to see which methods fit best for you and your device.

Human Factor

Sterling Medical Devices has decades of experience using human factor engineering in order to improve the design of medical devices. By using Human Factor Engineering to influence the design, Sterling can ensure the best compatibility between the user and the device.