Nortech Medical Solutions Capability
Nortech Medical Solutions – and its multidiscplinary capabilities – is positioned to help medical device OEMs realize their ideas and concepts. By providing these capabilities within one house, Nortech Systems can speed your time to market with our flexible and customizable Nortech Medical Solutions product and service offering. Our comprehensive solutions provide medical product and technology companies with a single source for quality, regulatory, human factors analysis and other device critical functions you may need to source out with other vendors.
Design & Engineering
Nortech Systems Solutions works with the IEC 62304 standard for developing medical device software, as well as using risk management tools. These systems, along with the Nortech Systems team’s extensive experience in developing software specifically for life-critical systems, are ideal for any client looking for a software development partner.
Nortech Medical Solutions puts together a team highly-experienced in working with common OS systems, as well as dedicated medical systems that provide additional benefits. Additionally our medical solutions can focus on communication capabilities – included embedded short- and long-range wireless communication platforms – that enable connections with cloud systems, user APIs, and electronic health record systems. With Nortech Medical Solutions, you get a full team that will partner with you to develop a comprehensive strategy for device maintenance so your products can be confidently and securely be updated as needs dictate.
With Nortech Medical Solutions, you also leverage our electrical engineering team with over 100-years of collective experience in designing specifically for medical devices, including capital equipment, wearables and everything in between. Nortech Systems engineers work with various platforms, including traditional PCBAs, rigid flex and true flex designs, to bring together application needs, cost effectiveness and repairability.
Mechanical engineering touches virtually every aspect of a medical device’s appearance, function, and certification compliance. Nortech Medical Solutions provide a mechanical engineering team with expertise in using Phase Gate design methodology, while using a rigorous approach employing five phases; from concept development to commercialization. With users, we define requirements, target values, and minimum acceptable values for each aspect of a device, taking OSHA and FDA guidelines into account. Beginning with conceptual sketches and moving towards more elaborate models, we create and test prototype devices and manufacture initial units for design verification testing.
Our industrial design process is flexible, taking into consideration each of our clients’ unique needs. Whether your requirements dictate a fast track approach to creating inspiring and compelling product aesthetics, or the creation of a high level branding and design language strategy, Nortech Medical Solutions can deliver. Experience and use of state of the art visualization tools will insure that our industrial design efforts will meet or exceed your specific needs.
In addition, the Human Factors expertise – including an onsite HFA laboratory – helps address specific medical device submission requirements and allows you to build your new devices with confidence.
Nortech Medical Solutions provides a team that works in a unique way within the industry; we use worldclass project management, including pooled resource tracking and estimation, to not only give prospective clients accurate project estimates at the proposal phase, but also use it on a rolling basis to track and advise on project status as the project progresses, giving clients the opportunity to adjust their approaches.
Quality Management & Systems
For all regulated medical devices, fulfilling quality obligations is an essential requirement. At Nortech Systems, we have experience in working with multiple scenarios to offer quality services. For companies with no existing QMS, we offer Nortech Medical Solutions to customize a standalone system that will help provide ISO and UL certification for your devices and their design. For larger OEMs with their own quality systems in place, we will work with those clients on a crossover plan to transfer our designs to your documentation and requirements with minimal excess work.
Regulatory Services & Support
Over the past ten yearsplus, Nortech Systems has worked to support its vendors for regulatory submissions and requirements. We have experience working in multiple environments, including:
- Class I, II and III US FDA submissions;
- European Union / CE Mark submissions;
- Japan shonin submissions;
- HealthCanada submissions;
- And much more.
The Nortech Medical Solutions documentation system and risk management processes – including ISO 14971 Certification – mean that you get a solution that has an ideal structure to support initial submission and followup protections for audits and legal requirements.
Production & Post-Market Services
Initial & Full-Rate Production
At Nortech Systems, we can serve as your one-stop-shop into production needs. Our Nortech Medical Solutions offer FDA Registered, ISO 9001 and 13485 Certified manufacturing capabilities, including prototyping, custom wire/cable production, printed circuit board (PCB) production, and integration & final assembly.
Nortech Medical Solutions provide a unique benefit in moving to commercialization. The integrated processes allow the team to move a project from design to production with much less effort than a standalone design house would experience with a normal third-party vendor. Additionally, Nortech Systems staff is available to assist with final production elements as required, so you know we’ll stand by your project through commercial shipments.
Nortech Medical Solutions provides total production options and comprehensive post-market service options. The solution’s team will work with you on warehousing, repair, refurbishment, and recycling so your product receives the complete support it will need to excel in today’s health care environment.
Additionally, if any design elements are involved, Nortech Medical Solutions can address issues or concerns as they are found, meaning no learning curve and no time wasted.