Services We Offer

Wherever you are in the medical device development process, Sterling Medical Devices will add immediate value to your engineering efforts.

Development

Your engineering partner for bringing medical device products to market.

Testing

Medical device testing throughout the development lifecycle.

FDA/CE

Smart, cost effective verification services for medical device companies.

Project Rescue

Are you looking to get your medical device project back on track? Our engineers are here to help.

Custom design & development for your medical device

Sterling Medical Devices provides wide-ranging medical device services to help take your idea or project from concept to market. Our breadth of experience in medical device development, medical device design, medical device software development, and medical device testing, is further enhanced by our expertise and success in helping clients maximize their chances of success during the FDA and CE approval process.

Avoid obstacles and save time with a great design from our highly qualified engineering team.

Your engineering partner for bringing medical device products to market.

Development Medical Device

What our clients are saying

“The work was done proactively and timely. The team was very skilled, providing
high quality deliverables.”

Medical Device Development Client

“The Sterling staff involved with the project were excellent. They were professional
courteous and responsive to our needs, and they provided the expertise we were
seeking.”

Gap Analysis Client

“Sterling made the process very smooth and was responsive to my emails and
requests.”

Tool Validation Client

“The persistence, determination, and attention to detail put into locating and
resolving bugs speaks to a high standard of quality.”

Software Development Client

“Working with Sterling has always been extremely productive. They have helped us
since we started the company and the work is outstanding”

Quality System Client

US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

What does it mean for the Medical Device industry? The current ever-changing landscape of cybersecurity threats and hazards, amongst ransomware campaigns and remote vulnerability cracks, call for medical device manufacturers …
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Software FMEA

The Effective Software FMEA Risk Management Approach Software FMEA, also known as Software Failure Modes and Effects Analysis, is a specific method of risk management that pertains to identifying single-fault …
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ISO 14971

Considered the internationally accepted standard for the medical device industry, ISO 14971 is a guide for risk management of medical device manufacturing.
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