Medical Engineering and Design

Partner with a true expert in medical engineering & design. Our team uses their knowledge of product design, biomedicine and more to help advance our clients. Nortech designs, develops and manufactures Class I, II, and III medical devices. We have a development team exclusively focused on medical products, experienced in clinical applications of capital and disposable products, including cardiology systems, orthopedic equipment, surgical devices, point-of-care diagnostic instruments and therapeutic devices.

Medical Engineering and Design

Our engineers use their knowledge of product design, biomedicine, electronics, mechanics, and control systems to design, develop, and manufacture Class I, II, and III medical devices. We have a development team exclusively focused on medical products, experienced in clinical applications of capital and disposable products, including cardiology systems, orthopedic equipment, surgical devices, point-of-care diagnostic instruments, and therapeutic devices.

Medical Device Engineering & Design Expertise

Some of our specific medical device design proficiencies include:

IEC 62304, safety-critical embedded software, including RTOS implementations extending to device applications.
Custom functional and design requirements for cardiology, orthopedic and surgical systems, point-of-care diagnostic instruments and therapeutic devices (including stimulators).
Custom board design, power management, motor control and signal processing for sensitive analog signals, RF and communications.
Cross-functional engineering teams embedded within manufacturing and quality, providing design for manufacturability perspectives to ensure production-ready designs.
Additive processes for manufacturing such as molding, stamping, machining, etc.

Our services also cover everything from finished products to subsystems and interconnects. We also provide qualification and acceptance test planning, tooling and fixturing, and mechanical and environmental ruggedization. Nortech is skilled in architecture simplification, copper and optical hybrid technologies and embedded diagnostics.

Work With Nortech to Create & Advance Devices Needed to Improve the Lives of Healthcare Staff and Patients Worldwide

Expertise in Complex Balun Design Challenges

Perfectly tuned baluns can reduce electromagnetic interference and shield currents, providing a safe patient environment. Reaching design consensus quickly, maximizing commercial success and getting FDA approval with minimal effort will help you achieve fast results and superior patient care with confidence.

Having an electromechanical manufacturing services partner with expertise in complex balun design challenges is crucial. This detail alone can determine the success of any project. Early engagement with our team means quick prototyping to accelerate development and on-site testing. Nortech ensures all products meet the highest standards for quality, speed and safety. As a result, you can maximize potential revenue and client partnerships more efficiently.

Software Engineering

Do you need custom software for medical devices? Working with an experienced engineering team makes all the difference. Partner with an engineering team that is familiar with and can expertly handle custom board design, power management, motor control and safety-critical embedded software requirements among many others. This is essential in the development of medical devices for cardiology, orthopedic and surgical systems, point-of-care diagnostic instruments and therapeutic devices (including stimulators).

With extensive experience in this field, Nortech can anticipate potential problem areas and design solutions before they happen. As a result, you receive more robust products with better accuracy, compliance to regulations and higher quality that go to market swiftly.

Test Capabilities

Functional testing
Multi-facility equipment and process standardization
RF electrical length and phase tuning
EMI/EMC testing
Temperature cycling
Environmental sealing
Cable assembly flexture
High mating cycles
Optical performance
Custom IEC 62304 compliant testing and test deliverables
Test plans, test protocols, test cases, trace matrices
IEC 60601 certification process management
Design Validation Test [DVT] build
System verification test and reporting

Accelerate Commercialization

Accelerating the commercialization of medical device products requires a comprehensive approach. Deep expertise in design, development, testing and project management is needed to ensure the product is functional, efficient and meets the end user’s needs.

We start by leveraging our extensive medical engineering and design expertise to simplify and accelerate the process. During this phase we achieve time, cost and quality goals. Nortech’s flexible Quality Management System, with full component traceability, also helps streamline the regulatory approval process. Frequent and complete communication from our customizable program management process, will ensure that your production-ready product can launch into the market faster. Regardless of your company’s size, we will seamlessly support your goals.

Successful medical devices begin with thoughtful engineering and a clear path to manufacturability. Nortech’s medical engineering and design expertise helps transform innovative concepts into reliable, high-quality products built for performance and compliance. Ready to move your project forward?

Case Studies

Overcoming a Medical Device Manufacturing Blind Spot

Our embedded team enabled fast prototyping, testing and manufacturing of the technology being developed. This provided our client with a rapid shift to manufacturing, providing the speed necessary for successful market delivery and allowing them to recognize the value of our team’s efforts.

Strategic Solutions to Product Design and Launch

Our team provided the solution to our client’s problem with managing multiple suppliers and design iterations. Nortech’s disciplined approach and flexible quality system created a clear and consistent path for device approval, eliminating unforeseen setbacks and minimizing gaps.

Engaging A Strategic Partner for a Clear Path to Success

Through early engagement and leveraging our expertise, technology, and resources, we helped our client develop a detachable MRI table docking system. With our integrated team of engineers, daily progress updates, and data to streamline FDA approval, the technology designed and developed has been successfully implemented into healthcare facilities.

Removing In-house Resource Constraints

Are your projects being delayed because your engineering resources are over-allocated? Are inefficient design and testing leading to R&D cost overruns? Bring together your team with our in-house specialized resources to get everyone the answers they need on time and within budget.