Sterling Medical Devices
Sterling Medical Devices, a fully staffed U.S. based medical device engineering firm, is entirely dedicated to helping our clients resolve medical device design and development challenges“ from concept through completion “ by applying our expertise in the industry since 1998. Our medical device development group addresses the whole development process: systems, software, electronics, mechanical, quality, and compliance.
Company details
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- Business Type:
- Service provider
- Industry Type:
- Clinical Services
- Market Focus:
- Internationally (various countries)
This company also provides solutions for other industrial applications.
Please, visit the following links for more info:
About Us
Our staff consists of teams of medical device designers, medical device developer experts, and certified project managers, working exclusively on projects in the medical device design and development industry. We incorporate the most current FDA guidelines and regulations, best practices and latest tools in the industry for your development projects – or any parts of it, based on your company’s specific needs. We can help you optimize your budget and shorten development times for your Class l, ll, or lll device using the latest tools and technologies. If you have a technical issue or other challenge that is delaying your current project, we have the resources and expertise to jump right in and get your project back on track. Our approach allows our clients to get to market faster, streamline the regulatory process, minimize risk and save costs.
Unlike some of our competitors in the medical device design and development industry, we do not have a stake in the manufacturing revenue stream, so we do not reuse work that is not optimized for the product simply to move more quickly to the manufacturing phase, leaving you to defend design risk challenges to your product. We adhere to budget and schedule while designing our clients’ products with a focus on user needs, requirements, all the while making smart design choices based on our extensive and diverse product development experience.
Helping You Meet Regulatory Goals
Sterling Medical Devices is ISO13485 registered, IEC 62304 compliant as well as ISO 14971 and IEC 60601-1 compliant, so the work product we produce for our clients is consistent with the highest industry standards. Don’t yet have a quality system? You can rely on ours while in the process of achieving your own. Or, if you prefer, we can work with your team to develop your own quality system in a cost-effective manner. Our clients often leverage our ISO certified QMS, IT infrastructure, and experience.
Sterling owns and licenses the most up to date and advanced state-of-the-art tools and validated equipment and employs it on its clients’ projects so they can benefit from increased accuracy, efficiency and latest technology applied in tools. Sterling also offers its clients extensive IT infrastructure and real time backups of their work that is also transparent to them in real time. We own leading edge collaboration tools and use them in house.
Sterling offers the following advantages to its medical device design and development clients:
- U.S. based full time engineering staff
- Validated tools, staff trained
- Experts in regulatory concerns
- Extensive IT infrastructure/real-time backup
- Leading edge collaboration tools » polarion and skype for business
- Engineering/design focused with design for manufacturability
- Transparent, customer focused
- Next generation project management
- Project experience with companies from startups to the well established
- Startups leverage our ISO certified QMS, IT infrastructure, and experience
- The well-established utilize our talent and expertise to get the job done right
Why Sterling
At Sterling Medical Devices, we’ve been delivering medical device design innovation—from concept to market—for more than two decades, earning us the reputation as the best medical device consulting company on the market today.
What Sets Us Apart?
Faster time-to-market
We’ll incorporate the most current guidelines and regulations, best practices, and the latest tools in the industry to bring a superior product to market, quickly and cost-effectively. With vast experience, backed by proven quality systems, we know how to avoid the costly delays associated with the typical project—from innovation and development through testing, release, and beyond.
Unparalleled medical device innovations
Widely known as the best medical device consulting firm around, we take a customized, out-of-the-box approach to meeting your unique needs. With access to deep experience from our seasoned team of experts, you don’t just get a quality product with fast regulatory approvals—you get superior medical device design innovation, from concept to market.
ISO-certified
We are ISO 13485-registered, the industry’s most widely used international standard for quality management. We know all there is to know about the comprehensive requirements mandated by dozens of regulatory bodies worldwide—which translates to guaranteed quality assurance of your medical device.
In-house team of U.S.-based experts
Our team is comprised of the best medical device consultants in the industry, each of whom brings extensive experience in medical device design and development. We are 100% U.S.-based, and we’ve successfully completed hundreds of medical device projects like yours. This translates to a faster, more cost-effective market entry of your device.
Ongoing collaboration
At Sterling, you are part of the process. We’ll listen to you, understand your challenges, and partner with you to deliver medical device innovations for a quality product with quick regulatory approval. Whether serving as your full-time development team or aiding your existing team with a specific need, we will keep you well informed and involved throughout the entire process.