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Thought Leadership

Doctor on phone communicating with patient

Author: Jeff Chininis | September 26, 2023

Avoiding Pitfalls with Smartphone Medical Devices

Smartphones are everywhere. They help us pay our bills, keep our calendars, connect us to our colleagues and loved ones, save our most precious memories, and more. But did you know the value of...
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Medical professional using medical software.

Author: Dharma Kallur | September 21, 2023

Software as a Medical Device, Artificial Intelligence, and Machine Learning

Advancements in technology play a significant role in the medical device industry, especially regarding software. Software is integrated into many medical device products, but it can also be a...
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Medical device outsourcing breakdown graphic.

Author: Erik Hilliard | September 12, 2023

Questions You Should Ask Before Hiring a Medical Device Outsourcing Company

Designing and developing a medical device and bringing your product to market are two entirely different tasks—but both can be daunting for the experienced and inexperienced alike. If not...
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Medical professional using augmented reality medical software.

Author: Ben Holt | September 1, 2023

Exploring the Power and Potential of Augmented Reality Devices

Augmented reality (AR) technology is just about everywhere. We can take pictures of ourselves and superimpose a virtual shot of a haircut or a pair of pants to see how it would look on us. We can...
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Professional calculating medical device finances.

Author: Carrie Britton | August 22, 2023

FDA Medical Device User Fees (MDUFA) for 2024

On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and...
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Medical professional on the computer analyzing medical device software.

Author: Jamme Tan | July 14, 2023

Insight on Updated FDA Device Software Guidance

The US Food and Drug Administration (FDA) recently issued a new guidance document: Content of Premarket Submission for Device Software Functions. The revamp of the FDA’s software guidance for...
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Graphic that breakdowns the meaning behind a design history file and medical device development.

Author: Erik Hilliard | June 14, 2023

Design History Files: Everything You Should Know

Are you confused when it comes to understanding Design History Files (DHFs)? You're not alone. The complexities of Design History Files for medical devices can be intimidating, but once you...
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Woman using modern glucose monitor connected to laptop

Author: Matthew Calloway | June 6, 2023

First, Do No Harm: Ensuring Medical Device Connectivity Solutions are Safe and Secure

Digital health solutions, like wireless technology in healthcare and medical devices that use Wi-Fi, have, and will continue to transform healthcare. They enhance patient experiences, such as...
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Medical professional using a tablet

Author: Ashish Salunkhe | June 3, 2023

MDR Requirements for Post-Market Surveillance: Best Practices and Compliance Strategies

Struggling to keep up with post-market surveillance requirements for your medical devices? Do you worry about the potential risks and liabilities that come with failing to properly monitor...
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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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