Partner with Nortech to design your innovative technology for regulated medical device applications. We provide risk mitigation strategies, software design, program management and supporting documentation for regulatory submissions. Using our proven process, your project will advance to commercialization faster than ever before.
Nortech can design your innovative technology specifically for regulated medical device applications. This includes risk mitigation strategies, software design, program management and supporting documentation for regulatory submissions. Using our proven process, your project can move much faster to commercialization.
Nortech Systems is an ISO 13485-certified and 14971-compliant, multi-disciplinary engineering and manufacturing firm. We deliver innovative design solutions and comprehensive product development services to the medical device industry. Nortech is a full-service device and lifecycle management solutions provider.
The best way to approach a project is by starting with the end in mind. We do this by considering assembly, testing and serviceability requirements. Partner with an EMS provider, like Nortech, that can act as a single point of contact for all engineering and production needs. We maintain robust and flexible quality systems.
Nortech provides structure for project delivery through five coordinated phases. We will track and meet your project needs by customizing our process to your budget and resources.
Move from tactical order placement to strategic demand planning. The result will be better inventory availability, cost planning and revenue actualization.
We understand the importance of post-market support for the safety and reliability of your products. We offer value-added services, including automated replenishment, repair, refurbishment, recycling, product certification and compliance testing, and warranty support.
Do your medical-grade solutions have the highest level of design and support? When medical devices are designed with Design for Manufacturability (DFM) in mind, you can reduce prototype iterations. This helps streamline the production process, making it more efficient and cost-effective.
It also ensures that efficient testing and servicing options are not an afterthought. Medical devices must meet stringent safety and quality standards. Your manufacturing partner must have the necessary expertise to produce reliable, high-quality products.
Startups lacking a formal or experienced quality system can rely on Nortech’s ISO 13485 certified product development quality system as their own. For companies with an established quality system, the appropriate documentation will be created and transferred to their system according to their protocols.
Unlike many other vendors, Nortech Systems can design your innovative technology specifically for regulated medical device applications. We include risk mitigation strategies, human factors analysis and supporting documentation for regulatory body submissions.
We offer a complete suite of services including: concept development, feasibility studies, product design, development, prototyping and manufacturing support to meet your needs.
Commercialization of medical devices can be a long and challenging process. Even more so for products that are produced in low volumes or have a high-mix of components. Our Mankato and Bemidji, MN locations are tailor-made for these scenarios.
Excellent medical device contract manufacturers are able to quickly ramp up production to meet the market’s demands. This is all while maintaining a high level of quality control. When volumes reach a higher threshold, our facilities in China and Mexico can accommodate those production needs.
By working with a medical device contract manufacturer that can offer scalable solutions, your products get to market faster and with less risk. We also provide support throughout the product development process. From design and prototyping to manufacturing, packaging, testing, shipment, and post-market support, Nortech can support your needs.
Using our advanced technology and designs, your project can quickly move to commercialization compared to a project that starts from scratch. Our vendor partners work with us directly so we can support all aspects of your rollout, including supply chain management. Reduce your time and money spent managing vendors and subcontractors by making Nortech your one point of contact today.
Ready to get your medical-grade solution to market faster with a company that supports your products’ entire lifecycle?
Medical device manufacturing is a complex and regulated process. In order to bring your medical-grade solution to market, you need to work with a partner who understands the challenges and can support you through the entire lifecycle of your product.
We do this by:
Work with an ISO 13485 certified manufacturer, like Nortech, to have confidence that adequate testing is performed throughout the product development cycle. Board level testing reduces scrap in manufacturing. This ensures consistently low DPPM levels resulting in medical devices of the highest quality and safety for patients.
Whether your design is just a great idea, or you are ready to hand over your specifications and have contract manufacturing services take over, talk to our team of experts. We work every day to earn your trust and deliver value back to you through solid relationships, expert design and the right people.
Nortech Systems offers a full line of electronic manufacturing services, from design and development to commercialization and post-market support. We also offer a wide range of value-added services, such as Program Management and Quality Management, to help you navigate the product development landscape and ensure that your product meets your requirements.
Our experienced team makes it easy for you to help bring innovative, life-changing products to market quickly and safely.
Post-market support for your medical-grade solutions should start before your specifications transition to production. Skilled contract manufacturing partners will take time to consider the lifespan and service life expectations of your medical device. We also review components to ensure they allow for various installation scenarios and field maintenance access.
As a medical device contract manufacturer, we understand the importance of post-market support. Our services include testing design and implementation to ensure your devices perform as expected. We also offer flexible shipment options, including automated warehouse replenishment. In addition, we provide repair, refurbishment and recycling services to keep your devices in working order.
Nortech is committed to providing our customers with the highest level of service and support. Our experienced and knowledgeable team can provide ongoing design, manufacturing and post-market service options. As a result, you get even more value and peace of mind.
Nortech designs, develops and manufactures Class I, II, and III medical devices in numerous and various medical specialties. This includes but is not limited to cardiology, orthopedic and surgical systems, point-of-care diagnostic instruments, and therapeutic devices (including stimulators). Our team has expertise in:
With more than 20 years of medical device development experience, we understand the U.S. FDA and international medical device approval processes. Our team has a track record of successful approvals. Projects range from turnkey commercialization of technologies to task-based prototyping, post product service & support and sustaining engineering.
Nortech’s extensive experience in medical device manufacturing and your willingness to engage in a joint DFM process can be used to beat your competitors to market. Take advantage of our ability to identify and remedy design gaps. These benefits could include eliminating test iterations, ensuring a smooth production transition and keeping your medical devices fully functioning and servicing your customer’s critical needs well into the future.
Whether you are still concepting or have a fully functional design, we are ready to engage with you in all phases of the product lifecycle. As always, our Lean 6 Sigma continuous improvement process and dedicated quality teams are always thinking about how to deliver more to our clients through our certifications and best practices.
ISO 9001 Certified
ISO 13485 Certified
ISO 14971 Compliant
IEC 60601 Compliant (Electronic Medical Devices)
IEC 62304 Compliant (Medical Device Software)
IEC 62366 Compliant (Human Factors)
FDA Registered Facilities
