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Author: Sterling Medical Devices | July 9, 2021

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....

Author: Sterling Medical Devices | June 30, 2021

Obsolescence in Medical Devices

At Sterling Medical Devices, we know even small disruptions in the supply chain for the parts needed to produce your device can lead to big consequences for your business and patients.Obsolescence is...

Author: Dan Sterling | January 19, 2021

Human Factors Experts

Our Human Factors Team Expert: Tara MillerAt Sterling Medical Devices, Tara leads our human factors business. She brings over 15 years of experience in clinical studies focused on...

Author: Dan Sterling | January 19, 2021

Regulatory Affairs Experts

Our Regulatory Team Expert: Carrie Hetrick At Sterling Medical Devices, Carrie leads our regulatory, clinical, and compliance business. Carrie represents clients to both local and...

Author: Sterling Medical Devices | September 3, 2020

Human Factors Engineering

Human Factors EngineeringHuman Factors Engineering, or as some call it ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive...

Author: Sterling Medical Devices | January 22, 2020

Biomedical Device Development

Biomedical Device DevelopmentAs medical devices advance from hardware-based systems, the demand for biomedical device development has increased. Sterling Medical Devices is ready to help at any point...

Author: Sterling Medical Devices | January 22, 2020

IQ/OQ/PQ

IQ/OQ/PQInstallation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are three qualifications used to ensure the effectiveness and safety of the machinery and...

Author: Sterling Medical Devices | January 22, 2020

DHF Remediation

DHF RemediationIf you need a legacy product Design History File (DHF) to meet current standards, or if your product line is not in conformance with your quality system, Sterling Medical Device’s...

Author: Sterling Medical Devices | January 22, 2020

Medical Device Outsourcing

Medical Device OutsourcingFrom design, to engineering, to testing, and beyond, Sterling Medical Devices will work with you at any phase of the process. Our diverse set of services and credentials...

Resources

February 3, 2015

What is ISO 14971?

ISO 14971 is the application of a risk management process for medical devices. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk...

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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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September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....

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Registered U.S. Agent