At Northeast Biomedical, we created, and adhere to, an ISO 13485:2016 certified Quality Management System. Within this system, we use a 7 Phase development process. This exclusive process allows us to provide a structured and custom approach to each project.
Our individualized solutions help each client navigate through the device development journey with a solid management plan in place, a full understanding of budgetary considerations, and a reliable and experienced engineering team ready to transform its device concept into a fully-realized marketable product.
From the initial concept through market launch, Northeast Biomedical applies strategic planning and medical device design expertise to ensure a quality final product.
Phase 1: Evaluation
Discovery of the specific customer needs and idea generation to define the technology of the project.
Phase 2: Feasibility
In the second phase, a detailed prototype is built and tested per the engineering protocols of the product or a subsystem of the product.
Phase 3: Alpha Development
The Alpha design is the first complete product design cycle of the system or device. Augmented production methods will be utilized, but the components will be representative of the final design.
Phase 4: Beta Development
The final stage before launching into production.
Phase 5: Launch/Pilot Manufacture
During phase 5, there will be an initial production run of the device for products that could be sold to an end-user or customer.
Phase 6: Production
Upon successful launch of the product, cost-effective manufacturing is assessed, and the best production methods are selected.
Phase 7: Project Close-Out
In the final stage, we have the opportunity for us to revisit the project and ensure that the project was successful. This is a time to document the lessons that were learned and make notes of process improvement from both a project and a company perspective. The design team will be released from this program and reallocated to another program.
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