Medical Device Project Rescue

Project Rescue FAQs

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.

DHF Medical Device Remediation

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.

Resources

October 9, 2014

5 Mistakes Medical Device Startup Companies Need to Avoid

The path through the FDA approval process to market may seem perilous, but avoid these five common mistakes, follow advice from Sterling’s Bruce Swope and Erik Hilliard, and your 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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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