Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com

Mitigating risk through consistent testing.

Agile Medical Software Development

Agile is a type of risk management that mitigates risk by testing after each small change in your medical device.  Medical device software development is an ever-evolving field within the medical device industry, and it is growing increasingly complex in design and functionality.  The increase in complexity makes it extremely important to test your device after every small change to your software, in order to mitigate risk.

  • Design History File (DHF) Remediation
  • Get products to market quickly and cost efficiently
  • Utilize state-of-the-art tools and electronic test equipment
  • Proven track record of FDA/CE approvals
  • Software verification and validation testing

Sterling Medical Devices is ISO 13485 certified and we work with medical device companies throughout the entire software development lifecycle using state-of-the-art tools and equipment. Our team will help you to align your medical device software development efforts with FDA expectations and gain faster regulatory approvals. We can help you move toward your best practices, such as leveraging safety assurance case principles to clearly demonstrate the safety of your medical device product.

 
Contact Us
  • This field is for validation purposes and should be left unchanged.

About Sterling Medical Devices 

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

Share this!

Resources

medical device regulation compliance

October 22, 2021

Common Medical Device Regulatory Compliance Roadblocks

The medical device industry is heavily regulated by the FDA, specifically, the Center for Devices and Radiological Health. Unfortunately, while device manufacturers are required to establish and...
Read More >
View More Blogs

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.
Read More >
View More Videos
active drug delivery system

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....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis