Medical Device Project Management

DHF Remediation Service

We offer DHF Remediation services to create and update the design information necessary to validate and maintain the device throughout its lifecycle. This includes the identification of “gaps” in the existing technical documentation followed by the creation or update of the documentation to comply with applicable standards, regulations, and FDA guidance.

Are you looking to get your medical device project back on track? Our engineers are here to give you the advice and support you need at the right time. Questions to ask yourself about your specific project include:

Sterling Medical Devices is ISO 13485 certified and we work with medical device companies at any stage in their development lifecycle to ensure efficiency and bring your device to market.

With our familiarity of FDA regulations, Sterling helps relieve excessive regulatory burden by targeting specific aspects as valued by the industry. We have the experience and skills needed to quickly resolve your project development roadblocks.

Sterling Medical Devices has over 80 full time engineers on staff and the resources to take on any project you need assistance on. Check out our company overview page to learn more about our company.

Our engineers keep a constant level of communication not only with each other but with their clients as well using programs such as Polarion ALM to create a stress-free transparent environment.

We employ agile project management by breaking down the project into incremental steps, and then thoroughly reviewing each step. This allows us to efficiently make changes and receive company feedback. Check out our Risk Management page to learn more about how we mitigate risk and manage each project.

Sterling Medical Devices is equipped with different methods of medical device Tool Validation which gives our team the opportunity to see which methods fit best for you and your device.

With over 1100 projects in the medical device industry we have the experience to help ensure the success of your project.

Resources

design-medical-device-sharp

September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
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April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
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Potential Coronavirus Treatment

April 29, 2020

Sterling Medical Devices Partners with Cedars-Sinai and Aytu BioScience on Potential Coronavirus Treatment

MOONACHIE, NJ, April 29, 2020 — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, announced today their partnership with...
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Need help with your medical device?

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FDA/CE approval with a free custom project analysis.
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