Thought Leadership

Author: Dan Sterling | July 29, 2015

White Paper – 4 Factors to Consider When Developing Your mHealth Product

4 Factors to Consider When Developing Your mHealth Product Successful FDA submission of your mHealth product not only hinges on the accuracy of your data and reliability of your software, but on...

Author: Keith Handler | July 28, 2015

Is Your Medical Device an Entry Point for a Cyber Attack?

The Internet of Things (Iot), the continual proliferation of mobile medical devices, and the growing amount of data in hospital systems are trends medical device manufacturers should closely follow....

Author: Dan Sterling | July 7, 2015

Should the FDA’s Regulatory Oversight of Medical Device Apps be Limited Any Further?

The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly...

The 21st Century Cures Act - Medical Device Industry

Author: Dan Sterling | June 9, 2015

The 21st Century Cures Act: The Current Talk of the Medical Device Industry

A better approach than limiting the FDAs scope along certain criteria through legislation would be to allow the FDA to be more nimble and empowered, with oversight to prevent regulatory abuse. The...

Author: Dan Sterling | 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...

Author: Dan Sterling | January 27, 2015

Guidelines to Follow When Creating Mobile Medical Device Apps

Many new software applications are being developed for use on mobile platforms (smart phones, tablets, etc.). Before delving into the steps to be taken to develop such an application, we should first...

Author: Bruce Swope | October 9, 2014

5 Mistakes Medical Device Startup Companies Need to Avoid

The path through the FDA approval process to market may seem perilous, but avoid these five common mistakes, follow advice from Sterling’s Bruce Swope and Erik Hilliard, and your medical device...

Author: Dan Sterling | October 7, 2013

Guidelines to Follow When Creating A Medical Device Mobile Application

Guidelines to Follow Many new medical mobile applications are being developed for use on mobile platforms (smart phones, tablets, etc.). Before delving into the steps to be taken to develop a...

Author: Bruce Swope | November 12, 2012

Things You Should Know About Medical Device Development

Thought Leadership: Getting Your Medical Device through the FDA Approval Process Designing, developing and bringing to market a new medical device is a complex process. Here are some of the things...

Resources

Medical device engineers discussing project

February 25, 2023

Medical Device Engineering: It Takes All Types

Medical devices are highly regulated products that must be designed and developed according to stringent regulatory requirements and quality standards. A variety of expertise is needed in...

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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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Thought Leadership

White Paper – 4 Factors to Consider When Developing Your mHealth Product

Is Your Medical Device an Entry Point for a Cyber Attack?

Should the FDA’s Regulatory Oversight of Medical Device Apps be Limited Any Further?

The 21st Century Cures Act: The Current Talk of the Medical Device Industry

What is ISO 14971?

Guidelines to Follow When Creating Mobile Medical Device Apps

5 Mistakes Medical Device Startup Companies Need to Avoid

Guidelines to Follow When Creating A Medical Device Mobile Application

Things You Should Know About Medical Device Development

Resources

Medical Device Engineering: It Takes All Types

5 Mistakes Medical Device Startups Make

Implanted Drug Delivery System

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