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Author: Lorena Mosquera | February 28, 2023

Webinar Series: Medical Devices, Usability, and Human Factors

Medical Devices, Usability, and Human Factors: What you Need to KnowUsability is a must-have in the medical device industry. But are you perplexed about how to start incorporating usability into your...

Author: Lorena Mosquera | November 10, 2022

Commonly Overlooked Cybersecurity Threats

You’re Not Thinking of Them but Hackers AreTechnology is ever-evolving, ever-advancing, and ever-changing. With all its positives, technology has also created challenges. They are even more...

Author: Lorena Mosquera | October 18, 2022

How Regulatory Changes Can Impact Product Development

How Regulatory Changes Can Impact Product Development: Insights from Global MedTech Regulatory Trends: True Quality Summit SeriesThe MedTech global regulatory landscape is evolving. What is the...

Author: Sterling Medical Devices | September 7, 2022

Preparedness and Your Regulatory Strategy Whitepaper

Preparedness and Your Regulatory Strategy WhitepaperDoes your regulatory strategy come into play only at the end of your development process? If so, that’s a big mistake—one that can have...

Author: Sterling Medical Devices | June 26, 2021

The Importance of Post-Market Clinical Follow-up (PMCF)

The Importance of Post-Market Clinical Follow-up (PMCF) Under the EU MDR, post-market surveillance (PMS) is a critical quality control measure designed to identify risks associated with a device...

Author: Sterling Medical Devices | July 2, 2020

COVID-19 Regulatory Assistance for Medical Device EUAs

Are you struggling to achieve regulatory approval for a potentially life-saving medical device in this current COVID-19 environment? You may be able to file for an Emergency Use Authorization and...

Resources

Medical professional using medical device software

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...

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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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Whitepapers and Webinars

Webinar Series: Medical Devices, Usability, and Human Factors

Commonly Overlooked Cybersecurity Threats

How Regulatory Changes Can Impact Product Development

Preparedness and Your Regulatory Strategy Whitepaper

The Importance of Post-Market Clinical Follow-up (PMCF)

COVID-19 Regulatory Assistance for Medical Device EUAs

Resources

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

5 Mistakes Medical Device Startups Make

Implanted Drug Delivery System

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