Effective medical device design and development starts with understanding your needs and preparing a thorough project analysis and plan. RBC can help you – on target, on time, and on budget.
Medical device project management and design starts with structure but also many questions.
Medical Device Design & Development Services
- What is the intended use of the medical device?
- What intellectual property and technology is available for this medical device innovation?
- What do market, user, and patient experience say about the problem you seek to solve with your medical device?
- What are business and design risk factors?
- What are the regulatory considerations?
- Is there a predicate device and a path for FDA 510(k) clearance? Will we seek CE mark certification?
- What prototypes (preliminary or otherwise) will be needed for marketing, clinical, engineering, certification and other purposes?
- Are there any special supply/sourcing considerations?
- What are the estimated volumes for manufacturing?
- Most importantly, how will you define project success?
Of course, these questions are just the start of the medical device project management process. Then we cover a full “Procedures Checklist” of 36 major strategic and design considerations. With this clarity, you can be sure RBC has the insights and tools necessary for your success.
RBC Medical Innovations will assist you from concept to commercialization, including manufacturing in small lots by hand right here in the United States. Our portfolio ranges from critical care ventilators to handheld glucometers to RF ablation systems to new initiatives for start ups and more.
Whatever your medical device design and development project, we have a full complement of program managers, systems engineers, interaction designers, mechanical engineers, software engineers, and electrical engineers to kick off your project with a complete view of the opportunities and obstacles that lie ahead on the path to your launch.
Do you have the available resources and capabilities to transform your product development vision into a commercial medical device?
RBC Medical Innovations is ISO 13485 | ISO 9001 certified and FDA registered, with 23 years of experience supporting contract medical device design, development, and manufacturing. We focus exclusively on producing Class I, II, and III medical devices for FDA PMA or 510(k) clearance as well as international CE marking. Our clients partner with us in medical device project management and consulting because we have accomplishments that demonstrate we have the tools, resources, certifications, expertise and networks of help to transform their vision into reality.
510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.