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Author: Tara Miller | November 28, 2023

Tying PMS and PMCF Requirements Back to Risk Management

Medical device manufacturers’ obligation to meet regulatory requirements continues throughout the medical device lifecycle, including the post-production phase (post-market). Medical device manufacturers must implement an effective post-market surveillance system per the various applicable regulations. ...

Medical professional pointing at FDA icon.

Author: Ashish Salunkhe | November 3, 2023

An Overview of the FDA’s Application of Human Factors Engineering Principles for Combination Products Guidance

In September 2023, the FDA Office of Combination Products (OCP) released the Application of Human Factors Engineering Principles for Combination Products, a finalized version of the February...

Medical professional on laptop and phone with cybersecurity graphic.

Author: Ashish Salunkhe | October 17, 2023

FDA’s New Guidance for Cybersecurity in Medical Devices: What it Means for You

In September 2023, the FDA finalized its medical device cybersecurity guidance for premarket submissions. The updated document, “Cybersecurity in Medical Devices: Quality System Considerations...

Professional on computer reviewing ISO documents.

Author: Ashish Salunkhe & Carina Fleming | October 17, 2023

What’s New in ISO 10993-17:2023?

In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical...

Engineer on computer reviewing software design for medical device.

Author: Dharma Kallur | October 11, 2023

Mastering the Dynamics of Software Design for Medical Devices

Navigating the complex world of regulatory affairs for medical device software design can feel like trying to find your way out of a complex spider web. Each strand represents a different...

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...

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...

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...

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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Physician’s hand holding FDA approval sign

March 14, 2022

What is FDA Premarket Approval?

At Sterling, we have helped bring hundreds of medical devices to market. While the products vary, the questions posed by the companies developing them are often the same. They want to know what it...

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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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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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Thought Leadership

Tying PMS and PMCF Requirements Back to Risk Management

An Overview of the FDA’s Application of Human Factors Engineering Principles for Combination Products Guidance

FDA’s New Guidance for Cybersecurity in Medical Devices: What it Means for You

What’s New in ISO 10993-17:2023?

Mastering the Dynamics of Software Design for Medical Devices

Avoiding Pitfalls with Smartphone Medical Devices

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

Questions You Should Ask Before Hiring a Medical Device Outsourcing Company

Exploring the Power and Potential of Augmented Reality Devices

Resources

What is FDA Premarket Approval?

5 Mistakes Medical Device Startups Make

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

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