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Medical Device Project Rescue

At least once in your career, you are bound to feel the stress of a project that’s over budget and behind on schedule.

  • Are you experiencing technical challenges that are delaying your project?
  • Does it feel like you are too short staffed to get all the work done you need?
  • Has a regulatory body asked you to make changes to your product in a short period of time?
  • Do you lack the tools, experience, expertise, or breadth of knowledge to get your device to market?

Sterling Medical Devices can help.

We are the experienced partner you need to get your product done. Sterling Medical Devices is uniquely qualified to help you, with over 100 experts on staff and the resources to take on any challenges you face.

We are ISO 13485 certified, working with medical device companies at any stage in their development lifecycle to ensure efficiency and regulatory compliance, and bring your device to market.

We base our operations on our ingrained core values of integrity, problem solving, excellence, collaboration, and commitment to delivering for our customers. No matter what your roadblock is, we have the skills you need to help overcome it.  

Our project rescue services include:

Gap Assessment

We offer both on-site and remote audit and gap analysis services to help ensure your project and processes comply with relevant regulations, support safe and efficacious medical devices, and expedite time-to-market.

Hardware and Software Remediation

Overcoming design challenges is our specialty. Sterling Medical Devices has the industry knowledge and expertise you need. From hardware design to mobile apps, Sterling brings medical devices to the market faster, while ensuring things are done correctly the first time.

Design History Files (DHF) Remediation

We offer DHF remediation services to create and update the design information necessary to maintain your device throughout its lifecycle. Whether you need to update a legacy product DHF to meet current standards or your product line does not conform to the latest quality standards, our DHF remediation service offers you the support you need.

Resources

August 26, 2021

FDA’s Software Precertification Program

In today’s digital era, Software as a Medical Device (SaMD) is revolutionizing the healthcare field. From informing and driving medical decisions to diagnosing and treating patients, SaMDs offer a...
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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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Need help with your medical device?

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FDA/CE approval with a free custom project analysis.
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