Thought Leadership

Author: Carrie Britton | April 17, 2023

New FDA Guidelines for Artificial Intelligence and Machine Learning in Medicine and Medical Devices

Are you developing cutting-edge technology using artificial intelligence (AI) or machine learning (ML) in medicine? Are the vague regulatory requirements for AI and machine learning in medicine...

Medical professional using medical device software

Author: Bruce Swope | April 4, 2023

When Does Software Become Software as a Medical Device (SaMD)?

Do you know that under certain circumstances, your software or application can be considered a medical device? This is true even if there is no actual hardware involved — when the software IS...

Author: Erik Hilliard | March 16, 2023

Unlock Your Device’s Potential with an Expert Medical Device Engineering Company

As a medical device developer, you know that success depends on having the right team in place. But what does it take to find the right medical equipment engineers for your project? In this...

Medical device engineers discussing project

Author: Erik Hilliard | 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...

Author: Indre Larson | February 16, 2023

Is the FDA De Novo Pathway the Right Medical Device Regulatory Pathway for You?

If you're developing a medical device, you've probably heard of the FDA's De Novo classification process. You may be wondering if it's the right regulatory pathway for your device. In this blog...

Author: Carrie Britton | February 9, 2023

Unlocking the Mystery of Premarket Approvals (PMAs) and 510(k)s

Are you a medical device developer with questions about when and how to file for regulatory approval? Navigating the complexities of the FDA premarket approval process can be daunting. But it...

Man conducting third party compliance audit.

Author: Carrie Britton | February 2, 2023

Uncovering the Benefits of Third-Party Compliance Auditing

The importance of maintaining a high level of quality and compliance can’t be overstated for medical device companies. Failing to do so can put patients at risk, land you in hot water with...

Stethoscope holding down money with calculator and charts

Author: Steven Hartman, Larry Bischoff, Jamme Tan, & Jeff Triolo | January 26, 2023

Unraveling the High Costs Behind Medical Device Development

Developing medical devices is an expensive endeavor, but understanding the key components involved can help medical device companies better anticipate costs and estimate pricing. The overall...

Doctor showing medical supply chain process to avoid medical supply chain vulnerabilities.

Author: Larry Bischoff | January 24, 2023

Avoid Medical Device’s Supply Chain Vulnerabilities with These Five Tips

Supply chain breakdowns in medical device companies are becoming increasingly common. With the ever-evolving complexity of design and development processes, medical device developers are...

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.

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

New FDA Guidelines for Artificial Intelligence and Machine Learning in Medicine and Medical Devices

When Does Software Become Software as a Medical Device (SaMD)?

Unlock Your Device’s Potential with an Expert Medical Device Engineering Company

Medical Device Engineering: It Takes All Types

Is the FDA De Novo Pathway the Right Medical Device Regulatory Pathway for You?

Unlocking the Mystery of Premarket Approvals (PMAs) and 510(k)s

Uncovering the Benefits of Third-Party Compliance Auditing

Unraveling the High Costs Behind Medical Device Development

Avoid Medical Device’s Supply Chain Vulnerabilities with These Five Tips

Resources

FDA’s Software Precertification Program

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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