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

October 8, 2015

Developing Medical Device Software

"Developing Medical Device Software," New Med Device Online Article Series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device...
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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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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

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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Need help with your medical device?

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FDA/CE approval with a free custom project analysis.
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