Devicix – and its multi-discplinary capabilities – is positioned to help medical device OEMs realize their ideas and concepts. By providing these capabilities within one house, we can speed your time to market while providing one single source for quality, regulatory, human factors analysis and other medical device-critical functions you may need to source out with other vendors.
Engineering & Design
Production & Post-Market Services
Devicix works with the IEC 62304 standard for developing medical device software, as well as using risk management tools. These systems, along with our extensive experience in developing software specifically for life-critical systems, are ideal for any client looking for a software development partner.
Our team offers experience in working with common OS systems, as well as dedicated medical systems that provide additional benefits. Additionally we have worked with communication capabilities – included embedded short- and long-range wireless communication platforms – that enable connections with cloud systems, user APIs, and electronic health record systems. We will also work with you to develop a comprehensive strategy for device maintenance so your products can be confidently and securely be updated as needs dictate.
Our electrical engineering team is experienced at designing specifically for medical devices, including capital equipment, wearables and everything in-between. We 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. Devicix’s mechanical engineers use a Phase Gate design methodology, 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, we can deliver. Our experience and use of state of the art visualization tools will insure that our industrial design efforts will meet or exceed your specific need.
In addition, our Human Factors expertise – including an on-site HFA laboratory – helps address specific medical device submission requirements and allows you to build your new devices with confidence.
Devicix works in a unique way in our industry; we use world-class project management, including pooled resource tracking and estimation, to not only give our 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 we progress, giving clients the opportunity to adjust their approaches.
Quality Management & Systems
For all regulated medical devices, fulfilling quality obligations is an essential requirement. At Devicix, we have experience in working with multiple scenarios to offer quality services. For companies with no existing QMS, we offer 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.
Devicix is an ISO 13485 and ISO 14971 Certified vendor.
Regulatory Services & Support
Over the past ten years-plus, Devicix 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.
Our documentation system and risk management practices – including ISO 14971 Certification – mean that you get a vendor who has an ideal structure to support initial submission and follow-up protections for audits and legal requirements.
Initial & Full-Rate Production
At Devicix, we can serve as your one-stop shop into production needs. Our parent company – Nortech Systems, Inc. – offers FDA Registered, ISO 9001 and 13485 Certified manufacturing capabilities, including prototyping, custom wire/cable production, printed circuit board (PCB) production, and integration & final assembly.
The combination of Devicix and Nortech offers a unique benefit in moving to commercialization. Our integrated processes allow us 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, Devicix staff is available to assist with final production elements as required, so you know we’ll stand by your project through commercial shipments.
Not only does our parent Nortech offer total production options, but it also offers a comprehensive post-market service option as well. Nortech’s team will work with you for warehousing, repair, refurbishment, and recycling services 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, our paired systems means that Devicix personnel can help address any issues or concerns as they are found, meaning no learning curve and no time wasted.