Multiphased Approach

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.

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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. 

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. 

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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