At Nortech, we have the design expertise, test capabilities, and leadership experience to overcome these fit, cost, performance, and reliability challenges while meeting the strict regulatory requirements of the medical device industry.
Accelerating the commercialization of electronic medical devices requires a project plan that outlines the steps and resources needed to complete a project. In the context of medical device production, the project plan must include a detailed schedule, manufacturing strategy, clinical plan, regulatory plan, and quality plan review. The schedule should outline the timeline for all major project milestones, including the design, development, testing, and production phases.
The manufacturing strategy should describe the processes and resources that will be used to produce the medical device, including any outsourcing or in-sourcing decisions. The clinical, regulatory, and quality plans should outline the testing and evaluation that will be conducted to ensure the safety and effectiveness of the medical device, as well as outline the quality control processes that will be used to ensure that the medical device meets all regulatory requirements.
The project plan should also provide a framework for effectively managing risks associated with medical devices, as required by ISO 14971. This includes identifying and evaluating potential risks, implementing measures to mitigate those risks, and continuously monitoring and reviewing the effectiveness of these measures.
To excel at new product introduction, including PCB assemblies for electronic medical devices, takes a combination of factors, including accelerating time to commercialization by utilizing quick-turn prototyping services, having comprehensive yet flexible quality programs in place, working with a vertically integrated manufacturer, and having supply chain management that can effectively accommodate low-volume/high-mix production quantities.
Our medically focused development teams and our accomplishments in managing programs from start-ups to multi-national companies have made us proficient in each of these areas. Take advantage of our expertise to get your new product to market faster.
Nortech is a company that specializes in the design and production of integrated assemblies and box builds. Our engineering team helps customers fine-tune their assemblies for the manufacturing floor to drive out risks, waste, and non-value-adding activities to improve efficiency, reduce costs, and increase customer satisfaction.
We also offer a range of value-added services to meet your dynamic needs, including in-sourcing for wire/cable and PCB sub-assemblies, clean room assembly, and kanban programs. Our unique testing capabilities for box builds include high voltage and extreme environmental setups. Additionally, we have the tools and expertise to provide customers with well-built box builds and fully integrated devices, including engineering for manufacturability, lead production, and custom test fixtures/planning. Overall, we are dedicated to helping customers develop and build high-quality and reliable integrated assemblies and box builds.
Billions of IIoT devices are spewing out data every day, yet the vast majority of information goes unused....
Read More »
In the U.S, the FDA regulates the sale of medical device products. To gain the FDA’s approval to...
Read More »
Helping Kids Plant Their Future
