From design, to engineering, to testing, and beyond, your risk management process is an integral part for any phase of the project. Whether you are seeking to design a new medical device product or improve an existing device, your risk management process must be rigorous; especially if you are trying to get FDA & CE approval.
Sterling has decades of experience helping clients develop devices the right way! We understand that Quality Systems and how they are practiced are paramount in Medical Device Development and ultimately in obtaining medical regulatory compliance. That’s why all the work we do adheres to stringent guidelines in order to ensure your project is done correctly and timely.
Quality systems create the organizational structure for responsibilities, procedures, and resources of implementing quality management. With quality control, testing and inspections are done on components and finished products that go beyond the basics of verification and validation.
At Sterling, our team uses agile project management methods to eliminate extraneous elements that could threaten the medical device’s cybersecurity, create vulnerabilities, or present other potential risks associated with each individual medical device—all while moving the devices forward in the approval process.
When the time comes to validate your medical device software, no matter how far along you are in the development process, it is necessary to rely on an experienced partner that can guide you throughout the medical device software validation process
Sterling Medical Devices has decades of experience using human factors engineering in order to improve the design of medical devices. By using Human Factors Engineering to influence the design, Sterling can ensure the best compatibility between the user and the device.
April 30, 2020
February 18, 2021
November 23, 2020
