FDA / CE Medical Device Regulatory Compliance Consulting Services

Risk Management

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.

Manufacturing Compliance – GMP, QSR, ISO Review

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.

Other Services

Quality Systems

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.

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Cybersecurity

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.

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Tool Validation

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

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Human Factors

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.

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Registered U.S. Agent

According to the FDA’s Modernization Act of 1997, a company that manufactures, prepares, propagates, compounds, or processes a drug or device imported into the United States must identify a U.S. agent on its behalf. For devices in particular, each foreign establishment may designate a U.S. Agent who is either a resident of or maintains a place of business in the U.S. If you’re not sure where to start, we can help!

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Resources

September 23, 2015

When Medical Device Software Fails Due to Improper Verification and Validation

Software can be an essential component of your medical device, whether you’re designing a new product or improving the functionality of an existing one. Medical device software continues to change...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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