Sterling Medical Devices

Sterling Medical Devices Sterling Medical Devices is a provider of custom electro-mechanical and software solutions for the medical device industry.

We excel in medical device design, development, and consulting. Sterling Medical Devices develops medical device software for the industry. We have worked with such prestigious organizations as St. Jude Medical, Medtronic, Boston Scientific, Johnson and Johnson, Teleflex Medical, Hitronics Design, Continua Health Alliance, and Advanced Neuromodulation Systems. We have partnered with a number of ea

rly stage companies to help them bring products to the United State and European market. As reputable ISO 13485 registered software specialists in the medical device industry, Sterling Smartware is a leader in providing innovative software solutions for medical device companies. For more than 10 years we have supported our clients with the highest level of knowledge and commitment, optimizing our software processes for their specific needs. Working from concept to delivery, maintaining cost efficiency, reducing risk, and staying on schedule, we bring software and hardware together to solve our clients' needs. Sterling's philosophy is to work diligently to get the job done, whether it is getting product to market or troubleshooting challenging technical issues. We do whatever it takes to get the job done right, the first time, with the goal of meeting or exceeding FDA/CE regulations.

Tech advancements in medical devices, especially software, are reshaping the industry. As with any medical device sold i...
09/26/2023

Tech advancements in medical devices, especially software, are reshaping the industry. As with any medical device sold in the United States, software as a medical device (SaMD) is subject to regulation by the FDA. Knowing these regulations can fast-track your product to market, saving you time and money.

Explore our blog for an in-depth look at SaMD FDA regulations: https://bit.ly/45ZZsQu

3D printing is changing the medical device industry. The growth of 3D printing has helped medical device developers lowe...
08/30/2023

3D printing is changing the medical device industry. The growth of 3D printing has helped medical device developers lower costs but maintain quality. Have you considered 3D printing for your project?

Read our blog to learn more: https://bit.ly/3C8Ujsi

Developing a medical device is expensive. Understanding the costs and fees can help you create estimates and know what t...
08/28/2023

Developing a medical device is expensive. Understanding the costs and fees can help you create estimates and know what to anticipate when developing your projects.

Read our blog to learn the components that make up medical device costs: https://bit.ly/41GZ7k6

Big news for medical devices! The FDA has announced the fee rates and payment procedures for medical device user fees fo...
08/25/2023

Big news for medical devices! The FDA has announced the fee rates and payment procedures for medical device user fees for the upcoming fiscal year 2024. These fees play a vital role in speeding up the approval of safe medical devices in the U.S. market
Leverage our experienced team of design, development, and regulatory experts to drive your device to market: https://bit.ly/3qMi8Uv

The journey doesn't end once your product hits the market. Under the EU MDR, post-market surveillance (PMS) and post-mar...
07/28/2023

The journey doesn't end once your product hits the market. Under the EU MDR, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) are a critical part of ensuring the continued safety and effectiveness of your device. Our whitepaper offers valuable tips for conducting an effective PMCF study.

Ensure the ongoing success of your medical devices in the market. Download the whitepaper now. https://bit.ly/3iU1MT9

Meet David, our invaluable IT Support Specialist here at Sterling. In a world where everyone depends on IT, David stands...
07/27/2023

Meet David, our invaluable IT Support Specialist here at Sterling. In a world where everyone depends on IT, David stands out as a beacon of reliability. He's always ready with a smile and a solution, no matter how complex (or simple) the problem is. His patient, approachable demeanor makes tech issues less nerve-wracking.

Thank you, David, for your outstanding service to the entire team. Your hard work helps us deliver our best every day. Here's to many more years of success!

Learn more about our team: https://sterlingmedicaldevices.com/about-sterling-medical-device-design-and-development/expert-medical-device-makers/

07/26/2023

Understanding the end user's needs can often feel like solving a complex puzzle. Who will use your device? Where will it be used? These questions are crucial, yet finding the answers can sometimes seem like a daunting task. Our webinar digs into the importance of understanding user needs and offers practical guidance on how to effectively incorporate them into your medical device development process.

Get a direct link to this on-demand series and watch today!
https://bit.ly/3SYpfDa

Seeking help with updating your medical device documentation from MDD to MDR/IVDR compliance? We're here to help. Our re...
07/24/2023

Seeking help with updating your medical device documentation from MDD to MDR/IVDR compliance? We're here to help. Our regulatory services cover CE Mark documentation support, CER and PER development, PMCF plan updates, risk management file development, and more.

Don't wait to get started. https://bit.ly/35hY8KR

07/21/2023

Usability and human factors engineering in medical device development are essential, encompassing elements like learnability and memorability.

Want to delve deeper into this topic? Join us for a comprehensive webinar where we unpack the complexities of the usability process. Don't miss this opportunity to enhance your knowledge and stay at the forefront of industry innovation.

Get a direct link to this on-demand series and watch today!
https://bit.ly/3SYpfDa

Medical device development and production can often feel like walking on thin ice, especially when it comes to meeting r...
07/20/2023

Medical device development and production can often feel like walking on thin ice, especially when it comes to meeting regulatory standards. The fear of falling short and facing repercussions can be a constant worry.

We specialize in implementing robust Quality Management Systems (QMS) that ensure compliance, streamline processes, and ultimately keep your operations solidly on firm ground.

Together, we can make sure you're never walking on thin ice. https://bit.ly/35hY8KR

In the ever-evolving world of medical devices, risk management has taken center stage. We believe that risk management i...
07/19/2023

In the ever-evolving world of medical devices, risk management has taken center stage. We believe that risk management is not just about ticking off boxes on a compliance checklist. It's about creating medical devices that are safe, effective, and truly beneficial to end users. If you're looking for a development team that prioritizes risk management, reach out to us at Sterling.

Let's work together: https://bit.ly/35hY8KR

Even minor concerns with your device’s cybersecurity can result in an FDA denial. Sterling has ushered 100s of devices t...
07/18/2023

Even minor concerns with your device’s cybersecurity can result in an FDA denial.

Sterling has ushered 100s of devices through the complex maze of FDA regulatory requirements.

We can help you too.

Here are 4 strategies to help you meet FDA cybersecurity requirements. https://bit.ly/3Vh8qTE

Address

250 Moonachie Road #400
Moonachie, NJ
07074

Opening Hours

Monday 9am - 6pm
Tuesday 9am - 6pm
Wednesday 9am - 6pm
Thursday 9am - 6pm
Friday 9am - 6pm

Telephone

(201) 227-7569

Website

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